Technorati Tags: diet, exercise, type ii diabetes

Share This

“China now has the largest type 2 diabetes patient population in the world, and is the third largest market for type 2 diabetes agents, behind the United States and Japan,” said Decision Resources Analyst Jing Wu, M.S., M.B.A. “The type 2 diabetes market in China will continue to grow between 2009 and 2014 at an annual rate of 13 percent, which is faster than expected growth in the US or Japan.”

The report also finds that rising sales from newly launched Western-branded products will offset the generic erosion from older agents. The launches of three dipeptidyl peptidase-4 (DPP-IV) inhibitors—Merck’s Januvia, Novartis’s Galvus and Bristol-Myers Squibb/AstraZeneca’s Onglyza—and two glucagon-like peptide 1 (GLP-1) analogues—Novo Nordisk’s Victoza and Eli Lilly/Amylin/Alkerme’s Bydureon—between 2009 and 2014 will result in more than $270 million combined sales from these two drug classes in 2014.

“Increasing economic power in China and improvements in health insurance coverage has resulted in increased access to healthcare and the ability to afford expensive Western-branded drugs,” said Wu. “While metformin will continue to be the most widely prescribed agent in China because of its low cost and long-term physician familiarity, newly launched DPP-IV inhibitors and GLP-1 agonists will be used more frequently in the second or third line. The use of more Western brands will contribute to the expansion of the type 2 diabetes market in China.”

The new report features extensive primary research of Chinese endocrinologists in Beijing, Shanghai, Guangzhou, Tianjin and Wuhan as well as epidemiology data.

Technorati Tags: china, health, type 2 diabetes

Share This

Technorati Tags: avastatin, breast cancer, roche

Share This

In a letter sent today to dietary supplement manufacturers, the U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.

In recent years, FDA has alerted consumers to nearly 300 tainted products marketed as dietary supplements and received numerous complaints of injury associated with these products.

The FDA’s letter emphasizes that manufacturers and distributors are responsible for ensuring that their products comply with the law. Five major trade associations – Council for Responsible Nutrition, Natural Products Association, United Natural Products Alliance, Consumer Healthcare Products Association and American Herbal Products Association– are joining FDA on a call for media and have agreed to share the letter widely within the industry.

“These tainted products can cause serious adverse effects, including strokes, organ failure, and death,” said FDA Commissioner Margaret A. Hamburg, M.D. “The manufacturers selling these tainted products are operating outside the law.”

The FDA is seeking input and collaboration from dietary supplement trade associations to educate the industry about this problem and to help develop new strategies to combat it, according to Hamburg.

The agency also announced a new RSS feed¹ to warn consumers more quickly about tainted products marketed as dietary supplements.

The FDA has noted the three most common categories of these illegal products:

• Weight loss products² containing active ingredients such as sibutramine: Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn³ from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty⁴, Solo Slim⁵, Slim-30⁶, and others, which contain sibutramine or closely related drugs (analogs).
• Body-building products⁷ containing anabolic steroids or steroid analogs: These products can cause acute liver injury and increase the risk for heart attack, stroke and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.
• Sexual enhancement products⁸ that contain the same active ingredient or an analog of the active ingredient in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription, and they should not be used by people who have certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25⁹, Duro Extend Capsules for Men¹⁰, Magic Power Coffee¹¹, and others.

“The labeling of these tainted products may claim that they are ‘alternatives’ to FDA-approved drugs, or ‘legal’ alternatives to anabolic steroids,” said Michael Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research. “Consumers should avoid products marketed as supplements that claim to have effects similar to prescription drugs. Consumers should also be wary of products with labeling only in a foreign language or that are marketed through mass e-mails.”

Companies that make or distribute tainted products may receive warning letters and/or face enforcement actions such as product seizures, injunctions, and criminal prosecution. Responsible individuals may also face criminal prosecution.

Lawful dietary supplements contain minerals, vitamins or other dietary ingredients and are intended to be an addition to a standard diet. The FDA regulates these products under the Dietary Supplement Health and Education Act, passed by Congress in 1994. Unlike drugs, dietary supplements do not have to be approved by the FDA prior to marketing. Dietary supplement manufacturers and distributors are responsible for selling a safe product. FDA’s Current Good Manufacturing Practices require dietary supplement manufacturers to have proper manufacturing and quality assurance controls in place to ensure the quality of their products, including controls to prevent the inclusion of contaminants that could adulterate their products.

For more information:

Letter to Industry: http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/UCM236985.pdf¹²

Tainted Products Marketed as Dietary Supplements: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm236774.htm ¹³

RSS Feed: http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml¹⁴

Tainted Body Building Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/ucm234523.htm¹⁵

Tainted Sexual Enhancement Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234539.htm¹⁶

Tainted Weight Loss Products: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
MedicationHealthFraud/ucm234592.htm¹⁷

Photos of Tainted Products Marketed as Dietary Supplements: http://www.flickr.com/photos/fdaphotos/sets/72157625502079212/¹⁸

Dietary Supplements: http://www.fda.gov/Food/DietarySupplements/default.htm

Technorati Tags: diet, health, health supplements, weight loss

Share This

• Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online¹ or by calling 800-332-1088.
• Health care professionals should consider the possibility of ALCL if a patient has late onset, persistent fluid around the implant (peri-implant seroma). In cases of implant seroma, send fresh seroma fluid for pathology tests to rule out ALCL.
• There is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants.  Although not specific to ALCL, health care providers should follow standard medical recommendations.
• Women should monitor their breast implants and contact their doctor if they notice any changes.
• Women who are considering breast implant surgery should discuss the risks and benefits with their health care provider.

The FDA published its literature review in a document posted on FDA’s website site today titled “Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: Preliminary FDA Findings and Analyses.”
 
The FDA also plans to provide an update on its review of silicone gel-filled breast implants in the spring of 2011. This update will include interim findings from ongoing post-approval studies for silicone gel-filled breast implants currently sold in the United States, adverse event reports submitted to the FDA, and a review of the scientific literature on these products.
 
For more information:
 
ALCL and Breast Implants
² 
Breast Implant Consumer Information³
 

ALCL and Breast Implants Consumer Article

Technorati Tags: alac, breast implants, health

Share This

The agency concluded that the benefits of the drug — about 50% of patients were able to lose 5% of their body weight in clinical trials, compared with 10% of those receiving placebos — were not sufficient to outweigh the potential risks and the potential for abuse. Many patients receiving the drug had a slight increase in blood pressure and pulse rates.

The FDA notified the drug’s manufacturer, Orexigen Therapeutics Inc. of San Diego, that it would have to conduct a large clinical trial of the drug to test for possible cardiovascular complications in the elderly and the obese before the medication could be marketed, according to a statement released by the company.

Such a trial would probably take three to five years and cost as much as $200 million. Most analysts think such a trial is probably beyond the resources of Orexigen, which is focused solely on the development of anti-obesity drugs and has no other products on the market. The company’s stock fell 73% to close at $2.50 in Nasdaq trading Tuesday after the FDA announcement.

At a December meeting, the FDA advisory panel voted 13 to 7 in favor of approving Contrave, arguing that the potential cardiovascular problems could be addressed in a post-marketing study. If that had been the case, Orexigen’s marketing partner, Japan’s Takeda Pharmaceutical Co., would have shared in the cost of the study.

Contrave is a combination of two drugs already on the market: naltrexone, a drug used to combat alcohol and drug addiction, and bupropion, an antidepressant better known by its brand name Wellbutrin. Market analysts had predicted that, if approved, Contrave could have had yearly sales of $1.2 billion by 2018.

In October, the FDA rejected the proposed weight-loss drug Qnexa because of concerns about heart problems and birth defects. That same month, the agency rejected another experimental diet drug called Lorqess that appeared to cause tumor growth in animals. Also in October, the weight-loss drug Meridia was pulled from the market because of concerns that it boosted the rate of heart attacks and strokes.

Hence is seems like the FDA is exercising more vigilance in the approval of weighloss products, even though they are not considered as medicinal products. To me, that’s good news as it is time to product public safety as these products are too easily available to the public.

Technorati Tags: contrave, diet, fda, orexigen therapeutics

Share This

Technorati Tags: diet pills, fda, fruta planta, recall

Share This

As if things have not gotten more complicated already, now I’ve discovered that the itching I’ve been having for the last 2 years is Eczema.

It started off mild enough….once a month or so, there will be a slight itch that will go away after applying moisturizer for a couple of nights. Then last year, it was a little more sever, as I had gone on vacation in Italy, and the weather was too dry for me. The dry skin persisted on my hands, arms and legs, but it stopped after I applied some steroid cream from my doctor.

However, a few weeks later, the eczema flared up quite badly, such there there was sever itching. Within days, the dry skin had become leathery and red…..

I used steroid creams, despite knowing that it will thin the skin and bones…I was desperate. But it did not work….

steroid creams

I started to moisturize like crazy…….

I tried many different brands of moisturizers

I bought in bulk and stocked up!

After 6 months, spending a small fortune on creams, I stumbled on the eBook which helped me resolve my Eczema in 2 weeks!

Now I realize that Eczema is not a simple case of dry skin…the root cause lies in your immune system, your diet and understanding what you are eating, as well as how your body’s immune system works. Moisturizing your skin works on the dermis (upper skin layer), but not internally. Vitamins A and E are needed in your diet. On hindsight, I realized that I have neglected my health and diet due to my busy schedule. Since I followed the advice in the eBook, I have recoved from Eczema and have never felt healthier!

For Eczema suffers, don’t delay….visit the official website NOW!

You owe it to yourself to an itch-free life.

What Eczema looks like

Technorati Tags: best cure for eczema, best treatments for eczema, diet, eczema cure treatment, eczema cures for adults, eczema cures for children, eczema treatment cure, eczema treatments for adults, health, how to cure psoriasis naturally, natural cures for eczema in adults, new eczema treatment, new treatment for eczema, quickrelief psoriasis and eczema treatment, the best eczema treatment, the best treatment for eczema

Share This

Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females.  It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.

“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.

Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection  was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN.  Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well. 

Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination.  For all of the indications for use approved by the FDA, Gardasil’s full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Individuals recommended for anal cancer screening by their health care provider should not discontinue screening after receiving Gardasil.  

As of May 31, 2010, more than 65 million doses of Gardasil had been distributed worldwide, since its approval in 2006 according to the manufacturer, Merck and Co. Inc, of Whitehouse Station, N.J. The most commonly reported adverse events include fainting, pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries. This can be prevented by keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.
 

For more information:

Gardasil Product Page

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm237941.htm

Technorati Tags: anal cancer, gardisil, health

Share This

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease.

Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

Halaven’s safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist.

The study was designed to measure the length of time from when this treatment started until a patient’s death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.

“There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Halaven shows a clear survival benefit and is an important new option for women.”

The most common side effects reported by women treated with Halaven include a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.

Other FDA-approved therapies used to treat late-stage, refractory breast cancer include Xeloda (capecitabine) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; Ixempra (ixabepilone) for patients with late-stage disease after failure of an anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy.

Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.

Technorati Tags: breast cancer

Share This

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

Share This

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

Share This

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

Technorati Tags: health, weight loss

Share This

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.

RSS Feed for FDA News Releases

Technorati Tags: diet, health, weight loss

Share This

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.

#

RSS Feed for FDA News Releases

Technorati Tags: diet, fitness, health, weight loss

Share This

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

Technorati Tags: diet, health

Share This

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.

Technorati Tags: health

Share This

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

RSS Feed for FDA News Releases

Technorati Tags: diet, health

Share This

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.

RSS Feed for FDA News Releases

Technorati Tags: health

Share This

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.

RSS Feed for FDA News Releases [what is RSS?]

Technorati Tags: diet, exercise, health

Share This

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

Technorati Tags: diet, health

Share This

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.

RSS Feed for FDA News Releases

Technorati Tags: diet, health

Share This

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

RSS Feed for FDA News Releases

Technorati Tags: diet, health

Share This

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:

RSS Feed for FDA News Releases

Technorati Tags: health

Share This

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.

RSS Feed for FDA News Releases

Technorati Tags: diet, exercise, health

Share This