Aleglitazar is in a class of drugs called PPAR coagonists, meaning it can affect both glucose and fat (lipid) control. It also shares functional similarities with the thiazolidinedione family of drugs, along with, for example, rosiglitazone and pioglitazone. Both rosiglitazone and pioglitazone are well documented as effective agents for blood glucose control in patients with Type 2 diabetes, but both also have a number of safety concerns attached to their use.

A number of PPAR coagonists developed so far have been discontinued owing to toxic effects.

Professor Robert R. Henry, University of California, San Diego, and colleagues—authors of SYNCHRONY—were hopeful that aleglitazar could have a similar positive effect on glucose control, but without the accompanying safety issues.

In the Phase II randomized study, patients with Type 2 diabetes (either drug-naïve or treated with two or fewer oral agents) were enrolled from 47 sites in seven countries. Following a five-week run in period with all patients on placebo, 332 were randomized to 16 weeks of treatment with aleglitazar at once-daily doses of 50, 150, 300, 600 µg, or matching placebo (55 in each group), or to pioglitazone 45 mg once daily (57 patients) as a reference. The primary endpoint was the change in glycosylated haemoglobin concentration (HbA1c) from baseline to the end of treatment.

The researchers found that aleglitazar reduced baseline HbA1c versus placebo in a dose-dependent manner, from -0.36 percent with 50 µg to -1.35 percent at 600 µg. The trend of changes over time suggested that the maximum effect of aleglitazar on HbA1c concentration was not yet reached after 16 weeks of treatment.

Source: EurekAlert! 6/8/09

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The Phase III program will include more than 4,000 patients and will begin with five studies in early 2009. The objective of the program is to demonstrate durable efficacy and cardiovascular safety of albiglutide as mono- and add-on therapy. The primary efficacy endpoint for all studies will be the change from baseline in HbA1c compared to placebo and/or active comparators. A majority of the studies will include active comparators, including metformin, sulphonylurea, thiazolidinedione (TZD) insulin, and a dipeptidyl peptidase four inhibitor (DPP IV). The study duration is expected to be two to three years and the main dose and regimen for the programme will be 30 mg weekly.

Albiglutide is an investigational biological, injectable form of human GLP-1–a peptide that acts throughout the body to help maintain normal blood-sugar levels and to control appetite. In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced.

Albiglutide is the only medication that fuses human GLP-1 to human albumin. It is designed to have an extended duration of action and allow for weekly or less-frequent injections.

Source: PRNewswire 2/17/09

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Corcept Therapeutics in February announced additional positive results from a clinical study that tested whether Corlux® mitigates the weight gain and other metabolic effects associated with Risperdal®. The company previously announced top-line data demonstrating that adding Corlux to Risperdal treatment in healthy subjects resulted in a statistically significant reduction in weight gain compared to that seen in subjects receiving Risperdal alone.

Analysis of key secondary endpoints demonstrates that the addition of Corlux to Risperdal also results in less abdominal fat, lower fasting insulin levels, and lower triglyceride levels–all of which were statistically significant compared to treatment with Risperdal alone. Risperdal, a leading antipsychotic for the treatment of schizophrenia and bipolar disorder, is marketed by Johnson & Johnson.

Corlux is Corcept’s late-stage GR-II receptor antagonist, which the company is also evaluating in ongoing Phase III trials for psychotic depression and Cushing’s Syndrome. The results from this study confirmed results previously reported from a similar clinical study of Corlux when added to treatment with Zyprexa, which demonstrated statistically significant mitigation of Zyprexa-associated weight gain, as well as a favorable impact on metabolic markers.

The new study was a four-week randomized double-blind controlled trial in 75 lean, healthy men (body mass index of 23 or less). Subjects were randomized to receive either Risperdal plus placebo (n=30), Risperdal plus Corlux (n=30), or Corlux plus placebo (n=15).

Daily weights were recorded, as well as abdominal fat (as measured by waist circumference), fasting insulin, and triglycerides. Subjects in the Risperdal alone group gained an average of 9.2 pounds, compared to a gain of 5.1 pounds in the Risperdal plus Corlux group. The increase in abdominal fat was 3.57 cm in the Risperdal alone group, compared to 2.03 cm in the Risperdal plus Corlux group. Fasting insulin increased by 10.97 mU/L in the Risperdal alone group, compared to 1.80 mU/L in the Risperdal plus Corlux group. In addition, triglycerides increased by 30.57 mg/dL in the Risperdal alone group, compared to an increase of only 3.13 mg/dL in the Risperdal plus Corlux group.

Source: Marketwire 2/23/09

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The U.S. Food and Drug Administration is warning consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing sibutramine. Sibutramine, a controlled substance with risks for abuse or addiction, is a potent drug that poses potential safety risks.

“Sibutramine is the active ingredient in an FDA-approved prescription drug used as an appetite suppressant for weight loss,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “But when present in a dietary supplement, it may harm unsuspecting consumers because sibutramine can substantially increase blood pressure and heart rate (pulse), and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats or stroke.”

Venom HYPERDRIVE 3.0 is marketed by Applied Lifescience Research Industries Inc. (ALR Industries), Oak View, Calif. On Dec. 24, 2008, ALR Industries initiated a recall of all lots of Venom HYPERDRIVE 3.0 after the FDA laboratory analysis showed samples of the product contained undeclared sibutramine. Although ALR Industries claims on its Web site that only “trace amounts” of sibutramine were found in this product, the FDA laboratory tests showed that Venom HYPERDRIVE 3.0 contains a significant amount of sibutramine per dosage unit.

The product was sold via distributors and in retail stores nationwide as well as in Canada, Poland, Sweden, Hungary, South Africa, the Netherlands, Australia, France and the United Kingdom. The product was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743.

Consumers who have this product should stop taking it immediately and contact their health care professional if they have experienced any adverse effects. Consumers can contact the company at legal@alrindustries.com to receive further instructions for returning the product and to ask any questions.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

• Online
• Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088

For an updated list of all tainted weight loss products, go to: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html.

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The U.S. Food and Drug Administration is expanding, for the second time, its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients.

The FDA has identified additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat). The current list now includes the following 72 products:

* This product should not be confused with the line of meal replacement and related products that are marketed as conventional foods under the brand name “Slim-Fast®”.  The manufacturer of Slim-Fast®, Unilever United States, Inc., maintains that the Slim Fast product which appears on this list is not in any way associated with, sponsored or approved by, or otherwise related in any way to the Slim-Fast® brand of meal replacement and related products.

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed maximum recommended dosages,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Consumers have no way of knowing that these products contain dangerous drugs that could cause serious consequences to their health.”

On Dec. 22, 2008, the FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. On Jan. 8, 2009, the FDA expanded the list of tainted weight loss products to include 41 additional tainted products. The FDA will continue to update this list as warranted.

The products listed above, some of which are marketed as dietary supplements, are promoted and sold on various Web sites and in some retail stores and beauty salons. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the products’ labels or in promotional advertisements. These products have not been approved by the FDA, are illegal, and include the following undeclared active pharmaceutical ingredients:

• sibutramine (an appetite suppressant available by prescription only and a controlled substance)
• fenproporex – a controlled substance not approved for marketing in the United States;
• fluoxetine – an antidepressant available by prescription only;
• bumetanide – a potent diuretic available by prescription only;
• furosemide – a potent diuretic available by prescription only;
• rimonabant – a drug not approved for marketing in the United States;
• cetilistat – an experimental obesity drug not approved for marketing in the United States;
• phenytoin – an anti-seizure medication available by prescription only; and
• phenolphthalein – a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.

The FDA has inspected a number of companies associated with the sale of these illegal products and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

The FDA advises consumers who have used any products containing these ingredients to stop taking them and consult their health care professional immediately. The FDA also encourages consumers to seek guidance from a health care professional before purchasing weight loss products.

The health risks posed by these products can be very serious and include high blood pressure, seizures, tachycardia (rapid heartbeat), palpitations, heart attack, and stroke. Sibutramine, a controlled substance, was found in many of these products at levels much higher than the maximum daily dosage for Meridia, the only FDA-approved drug product containing sibutramine. These higher levels of sibutramine can increase the incidence and severity of these health risks. Fenproporex, another controlled substance, can cause arrhythmia and possible sudden death.

Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

• Online
• Regular Mail: use postage-paid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 800-FDA-0178
• Phone: 800-FDA-1088

For more information:

Information on FDA’s Initiative Against Contaminated Weight Loss Products

To learn more about the FDA’s initiative against unapproved drugs see the FDA’s Compliance Policy Guide at: http://www.fda.gov/cder/Guidance/6911fnl.htm.

For drug safety information, see: FDA’s Drug Safety Initiative.

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Here’s a recent consumer update from the FDA which I will like to share with you:

The Food and Drug Administration (FDA) is informing consumers of—and protecting them against—potential harm associated with unapproved products claiming to diagnose, prevent, or otherwise act against the 2009 H1N1 influenza virus.

Within the past two weeks, FDA has urged caution regarding promotions and Internet sites offering products for sale that claim to diagnose, prevent, mitigate, treat or cure the H1N1 flu virus enhanced efforts to warn about potentially deceptive H1N1 products, and encourage reporting of suspected criminal activity, with the release of an H1N1 flu fraud widget.
This portable application is embedded in an agency Web page (www.fda.gov/NewsEvents/PublicHealthFocus/ucm186340.htm) and can be copied onto any other Web site or blog.
with the Federal Trade Commission (FTC), issued a warning letter to a Web site marketing fraudulent supplements that claim to help prevent the spread of the H1N1 virus. The letter advises the site’s owners to discontinue marketing the products or face legal action.

 
Previous Actions
These new measures follow FDA actions earlier this year to protect consumers against Web sites offering unapproved products. These actions included enforcing laws that protect consumers against these sites, and warnings posted through media outreach and a “Fraudulent Products List” posted on FDA’s Web site at www.accessdata.fda.gov/scripts/h1n1flu/.

Since May 2009, FDA has warned more than 75 Web sites to stop the sale of more than 135 products with fraudulent H1N1 influenza virus claims.

“Products that are offered for sale with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” says Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “Unless these products and the claims they make are proven to be safe and effective, they will not prevent the transmission of the virus or offer effective remedies against infection. Furthermore, they can make matters worse by providing consumers with a false sense of protection.”

Buy Only FDA-Approved Products
Consumers are urged to only purchase FDA-approved products from licensed pharmacies located in the United States, and should contact their health professional if they have any questions or concerns about medical products or personal protective equipment.

Tamiflu (oseltamivir phosphate) and Relenza (zanamivir) are the only two FDA-approved antiviral drugs for treatment and prophylaxis of the 2009 H1N1 influenza virus. In addition to their approved labeling, these drugs have been issued Emergency Use Authorizations by FDA that describe specific authorized uses during the H1N1 public health emergency.

Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs.

An Assortment of Targeted Products
FDA actively monitors the Internet and, where appropriate, purchases and analyzes drug products. In October 2009, it announced what it found when it purchased and analyzed several products represented online as Tamiflu.

One of these online orders resulted in delivery to FDA of an unmarked envelope postmarked from India. Inside were unlabeled, white tablets taped between two pieces of paper that were found to contain talc and acetaminophen, an active ingredient found in many medicines to help relieve pain and reduce fever. Not found was oseltamivir, the active ingredient of Tamiflu.

The Web site selling this product disappeared shortly after FDA placed the order.

The agency also bought four other products purported to diagnose, prevent, treat or cure the H1N1 influenza virus from other Web sites. These products contained various levels of oseltamivir but were not approved for use in the United States. Several did not require a prescription from a health professional.

In actions it announced in June 2009, FDA issued warning letters and advised operators of offending sites to immediately ensure that they weren’t marketing products intended to act against the H1N1 flu virus that have not been cleared, approved, or authorized by the agency.

Among the unapproved, uncleared, or unauthorized H1N1 flu products it targeted at that time were

1)a shampoo said to protect against the H1N1 flu virus
2)a dietary supplement said to protect infants and young children from contracting the virus
3)a “new” supplement said to cure H1N1 flu infection within four to eight hours
4)a spray that claims to leave a layer of ionic silver on one’s hands that kills the flu virus
5)several diagnostic tests that have not been approved to detect the H1N1 flu virus
6)an electronic instrument whose sellers claim uses “photobiotic energy” and “deeply penetrating mega-frequency life-force energy waves” to strengthen the immune system and prevent symptoms associated with H1N1 viral infection

Work by FDA and the FTC to identify, investigate, and take regulatory action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products will continue. These efforts can include additional legal actions including seizure of products, injunction, or criminal prosecution.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
Here’s the link

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Diabetes is often associated with obesity. Apart from taking medication, there are other natural approaches which one can consider by consuming certain kinds of food.

High in fibre, barley is also a kidney cleanser. Better yet, regular intake of it helps prevent heart disease. BARLEY water was always a regular drink when we were still living at home. Whenever we had to go for a medical exam that included a urine test, my mum would make us drink barley water a day before it to make sure we got a positive result!

My mother was a wise woman. I later found out from an Australian
naturopath that barley is known to be a kidney cleanser.

Barley is good for your intestinal health too. Try to eat the barley
grains you find in your drink or sweet broth with fu chook (beancurd skin) and ginkgo nuts.

It’s high in fibre which feeds the friendly bacteria in the colon and
helps speed up the transit of fecal matter in it. In this way it helps
prevent haemorrhoids and colon cancer.

The propionic acid and beta glucan from barley’s insoluble fibre also help lower cholesterol and prevent the formation of gallstones.

Eating barley regularly is a preventive step against heart disease as,
besides the fibre content, it is also high in niacin, a B vitamin good for
lowering cholesterol.

Diabetics should eat more barley as the fibre will prevent blood sugar
levels from rising too high. It also provides relief from constipation or
diarrhoea for those suffering from Irritable Bowel Syndrome.

Barley is rich in selenium which prevents cancer and relieves symptoms of asthma and arthritis. It is a good source of manganese, copper and phosphorous.

Malt sugar comes from sprouted barley which, when fermented, is an ingredient in beer and other alcoholic beverages.

Barley, whose Latin name is hordeum vulgare, has been cultivated for more than 10,000 years.

Since ancient times, barley has been used for healing purposes and has
been known to the Chinese, Egyptians, Greeks and Romans. Athletes in
Greece and Rome in those days were known to eat barley bread to give them strength.

Besides the usual things we do with barley, I enjoy having it in a western soup. The larger pearl barley is used and I love the sticky bite of it.

Here’s a recipe for barley soup:

Barley soup with roasted garlic

1 cup pearl barley
5 cloves whole garlic, roasted
2 litres chicken stock, steeped from 1 chicken breast simmered in three litres water
2 tbsps vegetable oil
2 large onions, diced
2 carrots, diced
2 stalks celery, diced
150g turkey ham, cut up
1 tsp ground white pepper
1 tsps sea salt or to taste
1 tbsp chopped parsley

Method
1. Wash barley and soak it in a bowl of water for three hours. Drain.

2. Heat oil in pan and fry onions. Add carrots and celery, then the barley and fry for three minutes.

3. Add chicken stock, pepper and roasted garlic and simmer over low heat for at least an hour, or until barley is soft.

4. Add salt to taste and serve the soup garnished with chopped parsley.

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The U.S. District Court for the Eastern District of Michigan, Southern Division, today entered a consent decree that condemns and forfeits to the United States for destruction about $1.3 million worth of dietary supplements.

“The court order is the result of efforts by the federal government to protect consumers from products for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury,” said Michael Chappell, FDA’s acting associate commissioner for regulatory affairs. “It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace.”

At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Mich. The seized products were marketed for use by body builders and distributed on the Internet and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.”

Based on laboratory tests, the FDA determined that the products contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to assure that the ingredients do not present a significant or unreasonable risk of illness or injury. Specifically, the condemned Methyl 1-D and Methyl 1-D XL contained 1,4,6-androstatriene-3,17-dione, also known as “ATD” or 1,4,6-etioallocholan-dione. The condemned Formadrol Extreme XL contained ATD and 3,6,17-androstenetrione (also known as “6-OXO”). Both of these substances are steroids that inhibit the activity of the enzyme aromatase and may be found in dietary supplements promoted to boost testosterone levels.

The FDA has no scientific information concerning the safety of the condemned products or their ingredients and, thus, cannot determine whether they represent a hazard to consumers. Under the circumstances, consumers who use or have used the products should discuss their use with their health care professionals.
The FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products’ use.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

• Online
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088

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The U.S. Food and Drug Administration today reaffirmed its position that elevated amounts of low-density lipoprotein (LDL), or “bad cholesterol,” are a risk factor for cardiovascular diseases such as heart attack, stroke and sudden death and that lowering LDL cholesterol reduces the risk of these diseases.

FDA’s comments are contained in an update to its Jan. 25, 2008, Early Communication describing the agency’s review of data from ENHANCE, a clinical trial comparing Zocor (simvastatin), a drug that lowers cholesterol production in the liver, to Vytorin, a drug that combines Zocor with another drug, Zetia (ezemtimibe), which inhibits cholesterol absorption.

Preliminary results from ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) had indicated there was no significant difference between Vytorin and Zocor-treated patients in the thickness of the walls of the blood vessels of the neck (the carotid arteries) although there was greater lowering of the amount of LDL cholesterol in patients with Vytorin compared to Zocor.

Measuring the thickness of the carotid arteries via ultrasound imaging is considered a biomarker of risk for cardiovascular disease.

FDA has now completed its review of the final clinical trial report of ENHANCE. After two years of treatment, there was no significant difference in carotid artery thickness between Vytorin patients and Zocor patients. However, the levels of LDL cholesterol, decreased by 56% in the Vytorin group and decreased by 39% in the Zocor group.
The results from ENHANCE do not change FDA’s position on the benefits of lowering LDL cholesterol. Based on currently available data, patients should not stop taking Vytorin or other cholesterol-lowering drugs and should talk to their doctor or other health care professional if they have any questions about Vytorin, Zetia or the ENHANCE trial.

FDA’s Early Communications are disclosures that the agency has begun evaluating new data about a drug and is considering regulatory action, but has yet to reach a conclusion.

The update is posted on FDA’s Web site.

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The U.S. Food and Drug Administration today approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

Like other statins, Livalo is intended for patients when diet and exercise fail to lower their cholesterol levels. Statins improve elevated blood cholesterol levels primarily by inhibiting a liver enzyme called HMG Co-A reductase, thus reducing the liver’s ability to make cholesterol.

“Elevated or abnormal cholesterol levels are associated with an increased risk for heart disease and stroke,” said Eric C. Colman, M.D., deputy director, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. “Today’s approval offers patients and their health care professionals another alternative way to treat high cholesterol.”

Livalo was approved on the basis of five clinical trials comparing its efficacy and safety to that of three currently marketed statins.

The most frequently reported adverse reactions from taking Livalo were muscle pain, back pain, joint pain and constipation.

Livalo is manufactured by Kowa Pharmaceuticals America Inc. of Montgomery, Ala.

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WASHINGTON - POPULAR US breakfast cereal Cheerios is a drug, at least if the claims made on the label by its manufacturer General Mills are anything to go by, the US Food and Drug Administration (FDA) has said.

‘Based on claims made on your product’s label, we have determined that your Cheerios Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug,’ the FDA said in a letter to General Mills which was posted on the federal agency’s website on Tuesday.

Cheerios labels claim that eating the cereal can help lower bad cholesterol, a risk factor for coronary heart disease, by four per cent in six weeks.

Citing a clinical study, the product labels also claim that eating two servings a day of Cheerios helps to reduce bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol, the FDA letter says.

Those claims indicate that Cheerios - said by General Mills to be the best-selling cereal in the United States - is intended to be used to lower cholesterol and prevent, lessen or treat the disease hypercholesterolemia, and to treat and prevent coronary heart disease.

‘Because of these intended uses, the product is a drug,’ the FDA concluded in its letter. Not only that, but Cheerios is a new drug because it has not been ‘recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease,’ the FDA said.

That means General Mills may not legally market Cheerios unless it applies for approval as a new drug or changes the way it labels the small, doughnut-shaped cereal, the FDA said.

General Mills defended the claims on Cheerios packaging, saying in a statement that Cheerios’ soluble fiber heart health claim has been FDA-approved for 12 years, and that its ‘lower your cholesterol four percent in six weeks’ message has been featured on the box for more than two years. The FDA’s quibble is not about whether Cheerios cereal is good for you but over ‘how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website,’ said General Mills.

‘We look forward to discussing this with FDA and to reaching a resolution.’ Meanwhile, the FDA warned in its letter that if General Mills fails to ‘correct the violations’ on its labels, boxes of Cheerios could disappear from supermarket and wholesaler shelves around the United States and the company could face legal action.

According to General Mills, one in eight boxes of cereal sold in the United States is a box of Cheerios. The cereal debuted on the US market in 1941. — AFP

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FDA Takes Enforcement Action Against Three New Jersey Dietary Supplement and Protein Powder Manufacturers
Companies failed to declare allergens in products and correct filthy conditions

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees operations at all three companies.

The companies, located in Paterson, N.J., manufacture dietary supplements and protein powders and distribute them throughout the United States. The companies also export powder mixes and dietary supplements for sale by private label customers.

The government’s complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.

The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems.

During a recent inspection, FDA investigators found that several of the companies’ products contained milk ingredients that were not declared on the product labels. In addition, the company failed to clean processing equipment between batches and control allergens in the facility.

FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.

In three inspections, FDA investigators noted deviations from GMP standards. The companies promised to make corrections, but they failed to do so. The complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.

“This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”

Consumers with allergies to milk ingredients who have used these products and are experiencing any symptoms should contact their health care professional.

Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.

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Agency issues Warning Letter to American Cellular Laboratories for marketing and distributing potentially harmful steroid-containing products

The U.S. Food and Drug Administration today issued a Public Health Advisory (PHA) warning consumers to stop using body building products that are represented as containing steroids or steroid-like substances. Many of these products are marketed as dietary supplements.

The agency also issued a Warning Letter to American Cellular Laboratories Inc. for marketing and distributing body building products containing synthetic steroid substances. Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.

The PHA notifies consumers and health care professionals that the FDA has received reports of serious adverse events associated with the use of body building products that claim to contain steroids or steroid-like substances. Those adverse events include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung). The PHA also advises consumers to stop taking body building products from any manufacturer that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.

The FDA has received five adverse event reports, including serious liver injury, in men taking products marketed as dietary supplements by American Cellular Laboratories including TREN-Xtreme and MASS Xtreme. Acute liver injury is generally known to be a possible side effect of using products that contain anabolic steroids. Some of the cases resulted in hospitalization, but there were no reports of death or acute liver failure.

“Products marketed for body building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA is taking enforcement action today to protect the public.”

The products listed in the Warning Letter to American Cellular Laboratories Inc.,  include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme,” and are sold on the Internet and in some stores. These products, which claim to contain steroid-like ingredients but in fact contain synthetic steroid substances, are unapproved new drugs because they are not generally recognized as safe and effective.  In addition, the products are misbranded because the label is misleading and does not provide adequate directions for use.

Consumers taking body building supplements that claim to contain steroids or steroid-like substances should stop taking them immediately. Consumers should also consult a health care professional if they suspect they are experiencing problems associated with the products. Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these types of products to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

To view the Public Health Advisory:
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm173935.htm

To view the July 27, 2009 Warning Letter to American Cellular Laboratories Inc., and the FDA consumer article on body building products marketed as containing steroids or steroid-like substances:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm173965.htm

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The U.S. Food and Drug Administration has approved Colcrys to treat acute flairs in patients with gout, a recurrent and painful form of arthritis, and patients with familial Mediterranean fever (FMF), an inherited inflammatory disorder. The medication’s active ingredient is colchicine, a complex compound derived from the dried seeds of a plant known as the autumn crocus or meadow saffron (Colchicum autumnale).

Colchicine has been used by healthcare practitioners for many years to treat gout but had not been approved by the FDA. The FDA has an initiative underway to bring unapproved, marketed products like colchicine under its regulatory framework. This initiative promotes the goal of assuring that all marketed drugs meet modern standards for safety, effectiveness, quality and labeling.

Physicians historically have given colchicine hourly for acute gout flares until the flare subsided or they had to stop treatment because the patient began experiencing gastrointestinal problems. A dosing study required as part of FDA approval demonstrated that one dose initially and a single additional dose after one hour was just as effective as continued hourly dosing for acute gout flares, but much less toxic. As a result, the drug is being approved for acute gout flares with the lower recommended dosing regimen.

The FDA is alerting healthcare professionals to this new dosing regimen and also warning about the potential for severe drug interactions when patients take colchicine.

The medicinal value of using colchicum was first identified in the first century A.D. and its use for treating acute gout dates back to 1810. Physicians have prescribed the medication since then. Although single-ingredient colchicine has not been approved by the FDA until now, a combination product containing colchicine and an agent that increased the excretion of uric acid in the urine was approved by the FDA in 1939.

FMF is the most common of the hereditary periodic fever syndromes and is characterized by recurrent episodes of fever, arthritis and painful inflammation of the lining layers of the lungs and abdomen.  Though rare in the United States, it is more common in Mediterranean countries. Physicians have prescribed colchicine for FMF for many years based on studies showing that it reduced the frequency of attacks but use of colchicine for FMF had never been approved. With this approval, Colcrys becomes the first drug approved to treat FMF.

Colcrys is manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia.

More Information:

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The U.S. Food and Drug Administration today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

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Medingo’s insulin patch approved; shares rocket

By Nick Taylor, 30-Jul-2009

Medingo’s insulin dispensing patch has been approved by the US Food and Drug Administration (FDA), sending shares in its parent company soaring to a 12 month high.

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In a guidance issued 6 Aug 2009, the U.S. Food and Drug Administration says that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.

Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides. If ingested in sufficient amounts, melamine can result in kidney failure and death.

Although the FDA has no reason to believe that the U.S. pharmaceutical supply is contaminated with melamine, recent events involving pet and livestock food products in the United States, and milk products for infants in China, underscore the potential problem.

The guidance is an initial measure by the agency in working with pharmaceutical manufacturers, repackers, other suppliers and pharmacists to conduct melamine testing. The agency invites comments on the guidance, available online and titled “Guidance for Industry: Pharmaceutical Components At Risk for Melamine Contamination“.

“The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry on this serious public health concern.”

The FDA identifies specific pharmaceutical ingredients in the guidance that are recommended to be screened for the presence of melamine. The guidance also recommends the use of FDA-published methods for this testing that are used to detect the presence of melamine in food proteins. These tests rely on equipment that is generally available to pharmaceutical manufacturers or contract testing labs. The agency also is developing a sampling and testing program for pharmaceutical ingredients at risk for melamine contamination.

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FDA Issues Public Health Advisory Regarding Levemir Insulin

The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.

The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots.

The agency is advising patients who use Levemir insulin to:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing.

3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.

4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions.

For more information:
Novo Nordisk news release

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At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized tuna salad sandwiches and other food products from Bearden Sandwich Company Inc., doing business as Southern Belle Sandwich Company, in Baton Rouge, La.

The seized products, totaling more than $72,000, violate the Federal Food, Drug, and Cosmetic Act because the products have been prepared, packed, and held under unsanitary conditions whereby they may have become contaminated with filth or rendered injurious to the public’s health (the Act uses the term “insanitary” to describe such conditions). In addition, the tuna fish salad sandwiches were processed under conditions that violate Seafood Hazard Analysis Critical Control Point (HACCP) regulations.

“When FDA investigators find violations inside a company’s facility, we will do what is necessary to keep insanitary and potentially harmful products out of consumers’ hands,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “Companies that are not complying with our laws will be subject to enforcement actions.”

Recent FDA inspections found evidence of widespread and active rodent and insect infestation, filthy conditions, and poor employee practices, such as allowing food-processing utensils to lie on the floor near live insects.

The company distributes products to convenience and retail stores in southern Louisiana; Mobile, Ala.; Montgomery, Ala.; and Crestview, Fla.

The FDA has not received reports of illnesses associated with consumption of the products. The FDA urges consumers who may have purchased the products to dispose of them in a safe manner and wash their hands thoroughly after handling the products. “Safe disposal” means avoiding bare-hand contact with the recalled products, discarding them in a way that will not allow people and pets to retrieve them, and washing items that came in contact with the products, including hands, with warm, soapy water.
Consumers can also report problems, including adverse reactions, to the FDA district office consumer complaint coordinator.

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Whatever happened to just enjoying good food, in moderation, without guilt?

If we buy into the common-sense wisdom found in books like the bestseller French Women Don’t Get Fat by Mireille Guiliano, it’s clear that the way to be thin and still have some joy with our meals is to adopt a more traditional, and worldly, way of dining. Moderate portions, fresh whole foods, relaxing and lingering with family and friends at the table — it’s what they do not just in France, but throughout the Mediterranean, Latin America and Asia. These are places where obesity rates have historically been low (at least until the global spread of fast food and sedentary lifestyles boosted obesity everywhere). It’s where the “gym workout” was a bicycle ride to work or school, or where eating a low-fat diet meant Mom stretching the meat by stuffing cabbage or grape leaves.

This reminds us that it is possible to eat what you love without feeling guilty, deprived or going on any restrictive regimen. Here’s how:

1. Start with soup.

This Japanese tradition is one of the best weight-loss strategies. That’s because eating soup, particularly the broth-based vegetable kind, before your entrée fills you up so you eat less during the meal, explains Barbara Rolls, Guthrie professor of nutrition at Penn State University in University Park, and author of The Volumetrics Eating Plan (HarperCollins, 2005). A two-year French study of 2,188 men and 2,849 women found that those who ate soup five to six times a week were more likely to have BMIs below 23 (considered lean), compared with infrequent- or non-eaters whose BMIs tended to be in the 27 range.

2. Make lunch your main meal.

Although they do this throughout Europe, a good explanation for eating your big meal at midday comes from ayurveda, India’s 5,000-year-old approach to wellness. “According to ayurveda, we’re actually designed to eat the larger meal at lunch because our digestive ‘fire,’ called agni, is strongest between 10 a.m. and 2 p.m., so we digest more efficiently,” explains Jennifer Workman, a Boulder, Colorado-based ayurveda specialist, registered dietitian and author of Stop Your Cravings (Free Press, 2001). “I’ve seen people in my practice lose 5 to 10 pounds just by doing this.”

3. Think quality, not quantity.

The French snub processed “diet foods” not found in nature, opting instead for high-quality meats, fish, produce, dairy, even desserts. When food is fresh and flavorful, you can be satisfied with smaller portions. This is the opposite of the American approach, which is to fill up on bland diet foods, then gorge on sweets later. “The French set the standard for small portions with their haute cuisine,” says David Katz, MD, author of The Way to Eat (Source Books, 2002). “If we consider that part of eating is to induce pleasure, if you can get there with quality of choice, you get there in fewer calories.”

4. Mix up the flavors.

In ayurveda, including the six basic tastes — sweet, sour, salty, bitter, pungent and astringent — is the key to a satisfying meal that won’t leave you craving junk food later.

Not sure where to start? This will cover all the flavor bases: Try salmon with yogurt dill sauce along with some sautéed kale topped with mango chutney, a sweet potato sprinkled with sea salt and a little clarified butter, and finish with a cup of chai and a small piece of dark chocolate.

5. Go for color.

The Japanese have a saying: “Not dressing up the meal with color is like going out without clothes.” Not only does color make food more attractive, but consciously seeking out colorful foods is a great way to bulk up your meals without a lot of calories. A Cornell University study of 6,500 adults in rural China found that while the Chinese ate about 30 percent more than the average American male, they weighed about 25 percent less, largely because they ate a lot of plant-based foods. The Japanese aim for five colors at each meal: red, blue-green, yellow, white and black, including things like red peppers, squash, broccoli, onions, black beans or black olives. “We’re variety seekers, so instead of seeking a variety of, say, cookies, get the variety from these low-energy-dense foods,” Rolls says.

Enjoy Yourself
Drizzle on the healthy oils. Healthy fats like olive oil, a staple of the Mediterranean diet, and canola oil, a staple of Okinawans, make vegetables tastier, so you’re likely to eat more of them. According to data from the Catalan Nutrition Survey done in Spain, people who ate the most olive oil also consumed more vegetables than those who consumed the least olive oil. And, as we know, eating a diet rich in produce is key to maintaining a healthy weight. In a study of more than 74,000 female nurses conducted over 12 years, Northwestern and Harvard University researchers discovered that those who added the most fruits and vegetables to their diets lowered their risk for major weight gain by 28 percent.

When you’re eating, just eat.

No other culture multitasks meals the way Americans do with our TV dinners, fast-food drive-throughs and grab-’n-go food that’s designed to fit into a car cup holder and be eaten with one hand. In Japan, it’s considered rude to eat while walking. And you’ll never catch the French gulping coffee in the car. “In France, there are no car cup holders because you don’t drink coffee while driving,” explains Will Clower, PhD, author of The Fat Fallacy: The French Diet Secrets to Permanent Weight Loss (Three Rivers Press, 2003). “Eating and drinking aren’t errands. It’s not what you do on the way to something else.” Good advice. When you’re distracted by work, traffic or the TV, you’re apt to overeat without even realizing it, notes Dean Ornish, MD, author of Eat More, Weigh Less (Perennial Books, 2001). “If you really pay attention to what you’re eating, you enjoy it more fully and don’t need as much food.”

Enjoy regular meals.

One reason French women don’t get fat is because French women eat three meals a day. You may think skipping meals cuts calories, but all it does is evoke a primal “fear of hunger response” that causes overeating later, explains Dr. Katz. “Throughout most of our history, we had too little to eat. So when you go for long periods without eating, you stir up all that native programming, which says eat like crazy when you can, because all too often you can’t.” Start with breakfast. Studies show that breakfast-eaters are slimmer than skippers.

Stop eating before you’re full.

The Okinawans, whose average BMI is 21.5 for those who eat a traditional diet, call this hara hachi bu, or eating till you’re 80 percent full. Of course, we’re not suggesting that you leave the table hungry. But eating until the buttons pop stretches the stomach by about 20 percent each time you do it, so you inevitably need more food to feel satisfied, explains Bradley Willcox, MD, co-author of The Okinawa Diet Plan (Random House, 2004). He says that putting your fork down “when you feel that first twinge of fullness” gives your brain a chance to realize that you are full before you overdo it.

Chow down only when you’re hungry.

Americans eat for all sorts of reasons besides hunger, especially from boredom, loneliness, stress or fear, a foreign concept in other cultures. “You can’t make food the solution to every issue in your life and expect to be thin,” says Dr. Katz. “If you eat from boredom, find a hobby. If you eat to relieve stress, learn meditation or yoga.”

Dine with others.

Eating with family or friends vs. alone in your car, at your desk or on the couch is part and parcel of traditional cultures. Not only does camaraderie make the meal more enjoyable, it’s slimming. “Eating with others restrains your own behavior,” notes Dr. Katz. “You eat more slowly, which increases the likelihood that you’ll register when you’re full before you’ve eaten more than you should.”

Have a glass of wine.

A staple of French and Mediterranean tables, wine adds joie to the meal, and because it contains potent antioxidants, is at least partly responsible for why these cultures traditionally have lower rates of cardiovascular disease and mortality despite their higher-fat diets. And while some studies show that we tend to eat more when we imbibe, a Finnish study actually found that male drinkers were leaner than abstainers.

Get moving.

People in Asian countries, France and the Mediterranean tend to be slim because they’re more active. Not that they spend hours at the gym; they simply walk a lot. It can work for Americans too. A study of 200,000 Americans at Rutgers University in New Brunswick, New Jersey, found that city dwellers were six pounds lighter than their suburban counterparts, largely because, instead of driving, they walked more. “You’re not working out,” says Dr. Clower. “You’re just moving.”

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The basic pyramid, developed by the USDA and the U.S. Department of Health and Human Services, is only one model. However, this pyramid has been adapted for ethnic preferences and there are now pyramids for the Mediterranean diet, the Asian diet and the Latin American diet. Other diets, such as the Hawaiian diet, can also be placed on a food pyramid.
How the Food Pyramid is constructed:

The food pyramid has four levels.

1. At its base, the foundation of a healthy diet, are bread, grains, and cereals. They should compose the largest percentage of what you consume.

2. Next come two food groups (vegetables and fruits) which, together, occupy the second tier of the pyramid.

3. On an even higher, smaller level you find the next two food groups: the milk and meat groups.

4. In the small triangle at the top of the pyramid sit fats and oils and sugars.
How to use the Food Pyramid:

Follow these simple steps.

1. Determine your calorie requirement

2. Translate your calorie requirement into daily food group allowances

3. Use the food group allowances to help you plan your meals and snacks

4. Record what you eat and check it against your daily allowances for each group

5. Use the Food Diary to record the areas where you are typically over your daily allowances

6. Try to alter the diet to be closer to your target
Here are a few simple practices to help get or keep you on track:

1. Choose a variety of foods from each major food group. This ensures that you get all of the calories, protein, vitamins, minerals and fiber you need. Choosing a wide range of foods also helps make your meals and snacks more interesting.
2. Adapt the plan to your specific tastes and preferences. For example, a serving of grains doesn’t only mean a slice of wheat bread. It can be wild rice, whole-wheat pasta, grits, bulgur, cornmeal muffins or even popcorn.
3. Combine foods from each major group however you like. For example, you might make a meal of tortillas (grain group) and beans (meat and beans group). Or you could top your fish with fruit salsa or serve steamed vegetables over pasta. The possibilities are endless.
4. Select your meals and snacks wisely. Make the most of what you eat by choosing nutrient-rich foods within each group. And if you need to avoid foods from one or more food groups — for example, if you don’t consume dairy products because of lactose intolerance — choose other foods that are good sources of the nutrients found in those foods.

How to fine-tune the Food Pyramid:

There are some challenges to using the USDA Food Pyramid. The first is that you need to put some distinction in your food choices, according to your particular dietary goals. For instance, if you are concerned about your weight, you will want to make your choices in the meat group from among those with lower fat content. The food pyramid doesn?t distinguish between hot dogs and lean chicken breast, so these distinctions are up to you.

After you have gone through this exercise a few times, you may find there are some foods that do not fit your diet plan. For instance, pizza may not be the best choice if you are trying to cut down on carbohydrates and fat, because it takes up too much of your daily allowance of each. If you don?t want to consume milk products, you may want to substitute additional carbohydrates.

Food pyramid differences:
Although food pyramids reflect the same general principles of healthy eating, they demonstrate different food choices. These differences reflect dietary preferences, food availability and cultural eating patterns. For example, the Latin American Diet Pyramid might include tortillas and cornmeal within the grains food group, whereas the Asian Diet Pyramid might emphasize noodles and rice.

Other differences include:

-Food groups. The food groups among food pyramids may vary somewhat. For example, some might group plant-based proteins — soybeans, beans and nuts — separately from animal proteins found in meat, poultry, eggs and dairy products. This is because animal proteins are often higher in fat and cholesterol, and some diets limit or avoid animal proteins.

-Serving recommendations. How food pyramids address servings also varies. The Mayo Clinic Healthy Weight Pyramid, for example, recommends a daily number of servings from each food group. And it specifically defines serving sizes; for example, a serving of cooked brown rice is 1/3 cup and a serving of milk is 1 cup. But other plans offer more general guidelines, such as eating particular foods at every meal, or on a weekly or monthly basis. For example, the Latin American Diet Pyramid recommends that you eat whole grains, vegetables and fruits at every meal but eat red meat, sweets and eggs once a week or less.

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Originally, this alert was sent to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients due to the potential risk of transmitting blood-borne pathogens such as HIV and the hepatitis viruses. However, I felt that this is something all diabetic patients should be aware of, so that if it happend to them, they are also well aware of the risks.

What’s the rationale for this alert?
Well, insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir or an insulin cartridge. The devices typically contain enough insulin for a patient to self-administer several doses of insulin before the reservoir or cartridge is empty. All insulin pens are approved only for single-patient use (one device for only one patient).

Apparently, the FDA was aware of incidents at two undisclosed hospitals involving more than 2,000 people in which the cartridge component of the insulin pens were used to administer insulin to multiple patients, although the disposable needles were reportedly changed among patients.

“Insulin pens are designed to be safe for one patient to use one pen multiple times with a new, fresh needle for each injection,” said Amy Egan, M.D., deputy director of safety at the FDA’s Division of Metabolism and Endocrinology Products in the Center for Drug Evaluation and Research. “Insulin pens are not designed, and are not safe, for one pen to be used by more than one patient, even if needles are changed between patients due to the risk of transmitting blood-borne pathogens.”

Patients exposed to shared insulin pens are being contacted by the two hospitals and are being offered testing for hepatitis and HIV. Some of the potentially exposed patients have reportedly tested positive for the hepatitis C virus, although it is not known if the virus was spread as a result of insulin pen sharing.

The FDA is working with the Centers for Disease Control and Prevention and professional organizations to address infection control issues related to insulin pens.

For us, as Diabetes patients, please be aware of the risks of sharing insulin catridges. If you see it being done at health care centres, stop the staff immediately and report the incident to the FDA. Also, don’t share the catridges amongst family members. Better safe than sorry!

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History of Phentermine -
In 1959 phentermine first received approval from the FDA as an appetite suppressing drug. Phentermine hydrochloride then became available in the early 1970s. It was previously sold as Fastin from King Pharmaceuticals for SmithKline Beecham, however in 1998 it was removed from the market. Medeva Pharmaceuticals sells the name brand of phentermine called Ionamin and Gate Pharmaceuticals sells it as Adipex-P. Phentermine is also currently sold as a generic. Since the drug was approved in 1959 there have been almost no clinical studies performed. The most recent study was in 1990 which combined phentermine with fenfluramine or dexfenfluramine and became known as Fen-Phen.

In 1997 after 24 cases of heart valve disease in Fen-Phen users, fenfluramine and dexfenfluramine were voluntarily taken off the market at the request of the FDA. Studies later proved that nearly 30% of people taking fenfluramine or dexfenfluramine had abnormal valve findings. The FDA did not ask manufacturers to remove phentermine from the market.

Phentermine is still available by itself in most countries, including the U.S. However, because it is similar to amphetamines, it is classified as a controlled substance in many countries. Internationally, phentermine is a schedule IV drug under the Convention on Psychotropic Substances. In the United States, it is classified as a Schedule IV controlled substance under the Controlled Substances Act.

What is phentermine?
Phentermine is a class of drugs called anorectics which decrease appetite by possibly changing brain levels of neurotransmitters associated with satiety. Phentermine is a stimulant that is similar to an amphetamine

• Phentermine Hydrochloride Oral tablet come in different commercial trade names:
  Adipex P (Immediate release)
  Anoxine-AM
  Ionamin (Slow Release Resin, Australia, discontinued in the US)
  Duromine (Slow Release Resin, New Zealand, Australia & South Africa)
  Fastin
  Mirapront
  Obephen
  Obermine
  Obestin-30
  Phentrol
  Phenterex
  Phentromin
  Pro-Fast SA
  Redusa
  Panbesy
  Phentermine Trenker
  Obenix
  Oby-Trim
  Teramine
  Zantryl
  Sinpet (MX)
  Supremin (PH)
  Umine (NZ)
  Weltmine (KP)

How does Phentermine work?
Phentermine stimulates nerves to release particular neurotransmitter called catecholamine. These include dopamine, epinephrine, (adrenaline) norepinephrine (noradrenaline). The increased levels of these chemicals appear to decrease the sense of hunger. Neurotransmitters are chemicals used to relay signal/messages in the brain.

These neurotransmitter eliminate the sense of hunger by putting your body in a small extent of “fight or flee’. This is the state your body takes when faced with danger. As you know if you see a car coming to hit you, you will not be aware of any hunger. Phentermine and other similar weight loss drugs like sibutramine and fenfluramine tend to mimic this state of “flight or flee” to some extent with their effect on neurotransmitters.

With the continued use of phentermine however, the effect of depressed appetite tend to wear off after a few weeks. This is why it is recommended for short term treatment. Some studies point to the possibility that this drug tolerance that results to reduced effect varies with individuals. One study has show phentermine to be still effective in a 3 year trial.

What is Phentermine used for?

It is a prescription weight loss pill that is used together with a Phentermine is used togther with diet and exercise to treat obesity (overweight) in people with risk factors such as high blood pressure, high cholesterol, or diabetes.

Phentermine may also be used for other purposes not listed in this medication guide.

What other information must I give my healthcare provider before taking Phentermine?

Taking phentermine together with other diet medications such as fenfluramine (Phen-Fen) or dexfenfluramine (Redux) can cause a rare fatal lung disorder called pulmonary hypertension. Do not take phentermine with any other diet medications without your doctor’s advice.

Do not take this medicine with any of the following medications:
•duloxetine
•MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
•medicines for colds or breathing difficulties like pseudoephedrine or phenylephrine
•procarbazine
•sibutramine
•SSRIs like citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline
•stimulants like dexmethylphenidate, methylphenidate or modafinil
•venlafaxine

This medicine may also interact with the following medications:
•medicines for diabetes

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Tell your healthcare provider if you have any of these conditions:
•agitation
•glaucoma
•heart disease
•high blood pressure
•history of substance abuse
•lung disease called Primary Pulmonary Hypertension (PPH)
•thyroid disease
•an unusual or allergic reaction to phentermine, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
If you have any of these conditions, you may need a dose adjustment or special tests during treatment.

What are some side effects of Phentermine?

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
•chest pain, palpitations
•depression or severe changes in mood
•increased blood pressure
•irritability
•nervousness or restlessness
•severe dizziness
•shortness of breath
•problems urinating
•unusual swelling of the legs
•vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•blurred vision or other eye problems
•changes in sexual ability or desire
•constipation or diarrhea
•difficulty sleeping
•dry mouth or unpleasant taste
•headache
•nausea

Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other precautions:

You may have withdrawal symptoms, such as depression and extreme tiredness, when you stop using phentermine after a long period of use. Do not stop using phentermine suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

It is not known whether phentermine will harm an unborn baby. Do not take phentermine without telling your doctor if you are pregnant. It is also not known whether phentermine passes into breast milk or if it could harm a nursing baby. Do not take phentermine without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone younger than 16 years old without the advice of a doctor. Phentermine may be habit-forming and should be used only by the person it was prescribed for. Phentermine should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. This medicine is usually taken 30 minutes before or 1 to 2 hours after breakfast. Avoid taking this medicine in the evening. It may interfere with sleep. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Remember to buy drugs from reliable sources. It is not advisable to buy phentermine online without a prescription. Do not rely on the packaging or appearance of the pills, as you have no evidence that the pills contain the registered ingredients at the correct dosage and purity that is mandated by the marketing authorities. Problems with the quality of cheap phentermine ordered online and delivered to your doorstap overnight is more common than you think. You really do pay for what you get and many cases of fraud go undetected until death occurs. So better to be safe than sorry.

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Goods fats vs. bad fats. You need to eat fats they are required for your health. Dr Udo Erasmus has said it already there are fats that heal and fats that kill. The problem is that most people are not aware of this and they choose for 100% fat free foods. A word of caution here the food can be 100% free but at the same time it can contain a lot of sugar.

Bad fats are:
- Trans fats.
- Saturated fats

Good fats are:

- Monounsaturated fats.
- Polyunsaturated fats.

In this article we concentrate us on a list of foods that contain bad fats.

High fat foods that are bad for you. Saturated fats. Studies have shown that diets high in saturated fats increase the risk of hart disease. They also increase the level of LDL (bad) cholesterol in your blood. Products that are high in saturated fats are.

- Butter
- Ice cream (contains milkfat)
- Cheese
- Chicken fat
- Meat fat
- Palm oil
- Coconut oil - Beef
- Lamb
- Pork
- Veal
A lot of animal products contain saturated fats and in some cases foods from plants.

Trans fats. Just like saturated fats there is a relationship between trans fats and bad cholesterol level. Products that contain trans fats are.
- Some margarines
- Cookies
- Crackers
- Snack foods
- Shortening
- Doughnuts
- Cake
- Frozen foods
- Potato chips
- Candy

Technorati Tags: diet, health

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Australia-based Garvan Institute of Medical Research, together with scientists

from the US and Slovakia, have done obesity research which have shown that

neuropeptide Y (NPY), a molecule the body releases when stressed, can

‘unlock’ Y2 receptors in the body’s fat cells, stimulating the cells to grow in

size and number. By blocking those receptors, it may be possible to prevent

fat growth, or make fat cells die.

“We have known for over a decade that there is a connection between chronic

stress and obesity,” said Professor Herzog. “We also know that NPY plays a

major role in other chronic stress-induced conditions, such as susceptibility

to infection. Now we have identified the exact pathway, or chain of molecular

events, that links chronic stress with obesity.”
“There is not much we can do about the increased levels of NPY caused by

stress, but we can do something about the damage it causes. If we can

interfere before it causes fat to amass, it could have a major impact on

cardiovascular disease, diabetes, and cancer (which all have links with

obesity). When we have a stress reaction, NPY levels rise in our bodies,

causing our heart rate and blood pressure to go up, among other things.

Stress reactions are normal, unavoidable, and generally serve a useful

purpose in life. It’s when stress is chronic that its effects become damaging,”

he said.
Scientists at Georgetown University (Washington DC), part of this

collaborative study, have found a direct connection between stress, a high

calorie diet and unexpectedly high weight gain. Stressed and unstressed

mice were fed normal diets and high calorie (high fat and high sugar, or so

called comfort food) diets. The mice on normal diets did not become obese.

However, stressed mice on high calorie diets gained twice as much fat as

unstressed mice on the same diet. The novel and unexpected finding was

that when stressed and non-stressed animals ate the same high calorie

foods, the stressed animals utilized and stored fat differently.
“Our findings suggest that we may be able to reverse or fidn treatments for

obesity caused by stress and diet, including the worst kind of obesity; the

apple-shaped type, which makes people more susceptible to heart disease

and diabetes,” said Professor Zofia Zukowska, the senior author of paper

published in Nature Medicine. “Using animal models, in which we have either

blocked the Y2 receptor, or selectively removed the gene from the abdominal

fat cells, we have shown that stressed mice on high calorie diets do not

become obese. Even more surprisingly, in addition to having flatter bellies,

adverse metabolic changes linked to stress and diet, which include glucose

intolerance and fatty liver, became markedly reduced. We do not know yet

exactly how that happens, but the effect was remarkable,” said Professor

Zukowska.
Professor Herzog believes that these research findings will have a profound

effect on the way society will deal with the obesity epidemic. “There are

millions of people around the world who have lived with high levels of stress for

so long their bodies think it’s ‘normal’. If these people also eat a high fat and

high sugar diet, which is what many do as a way to reduce their stress, they

will become obese. Until now, the pharmaceutical industry has focused on

appetite suppressants with only moderate success. Our hope is that in the

near future pharmaceutical companies, using the results of our research, will

develop antagonists against the Y2 receptor that will bring about a reduction

in fat cells.” . This could be a good approach in finding a treatment for obesity

and the key to obesity prevention.

Technorati Tags: diet

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