Agency alerts consumers to the finding of new undeclared drug ingredients

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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FDA alleged ‘Body-building’ products contained unapproved food additive, new dietary ingredient and these products will now be destroyed

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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Here’s another alert from the FDA on manufacturers Dietary supplements….

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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There has been alot of hype and talk about Phentermine as the bes diet pill in the market. However, before taking the drug, it is important to understand some basic facts.

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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You’ve heard the statistics, and you’ve seen the numbers. The number of overweight Americans is approaching 50%. Obesity levels are around 34% for all adults over the age of 20. The Standard Western Diet is loaded with foods with large amounts of sugar, fat and processed foods, which have been associated with unhealthy lifestyles such as cardiac disease, stroke, and diabetes.
Weight loss and weight gain can be reduced to simple math. Calorie weight loss happens when you use more calories than you take in

The purpose of any calorie intake for weight loss program is to finish with a negative balance. Or to put it another way, the total number of calories that you eat daily is less than the total number of calories you use by exercising and general living. This negative balance will result in weight loss.

This sounds easier than it really is to accomplish. Just be certain that you take in less calories per day by eating than you use up by living. Sounds simple, doesn’ it? Unfortunately, there are many factors that try to interfere with this simple formula. Such factors such as emotional eating disorders, various health issues, pregnancy or nursing will interfere with the ability to maintain a negative calorie intake for weight loss diet, whether it be a specific diet such as the Atkins Diet or Jennie Craig, or a diet that you created yourself.

Because it is so difficult for many people to maintain this negative calorie intake for weight loss diet, many have tried to find a simpler solution, such as a “magic” diet pill, surgery, patch or food. It has even led to the notion that there are certain foods that have a negative impact on calories because they supposedly take more calories to convert them to energy than they have stored in them.

You’ll learn that the negative calorie foods are supposedly asparagus, broccoli, beets, cabbage, cauliflower, celery, cucumber, carrot, garlic, papaya, spinach, turnip, zucchini, apples, oranges, lettuce, grapefruit, pineapples, strawberries and raspberries. The reasoning is that you can eat as much of these foods that you want, since they supply important nutrients, plus the added feature that you burn more calories getting to these nutrients than you gain from eating them

But look around at the animal kingdom. Herbivores are doing just fine, thank you, eating their fruits and berries. Calories must be present in these so-called negative foods, albeit in a smaller amount.

One pound of body weight is equivalent to 3500 calories. In order to lose one pound you have to have a calorie deficit of 3500 calories. That’s a simple enough math equation to remember. But remember too that this negative calorie weight loss deficit doesn’t happen in the course of one day.

For instance, let’s say that you normally eat 1800 calories per day to maintain your normal body weight. You then decrease your intake to 1500 calories while increasing the amount of exercise by 200 calories/day. It will take approximately 7 days to lose one pound. Weight loss is simply a mathematical equation that works when you apply it to your calorie weight loss program.

Gaining two or three pounds in one day is next to impossible. This is an example of water weight gain, or the body conserving water at the cellular level. This usually happens to the body during times of stress. You can easily lose the excess water stored in the body by actually increasing the amount of water you drink. The body then realizes that it has a source water and no longer retains anything extra, resulting in a loss of weight.

A negative calorie intake for weight loss schedule combined with increased calorie usage results in a safe weight loss program that becomes permanent as you acclimate yourself to the changes. Studies have also shown that weight loss becomes more permanent if exercise is made part of the general negative calorie weight loss program.

About the Author
Discover How to Get Yourself Properly Motivated to Stay on Your Diet. Get your free report ‘How to Take Your Dieting To the Next Level.” by downloading it here: Motivation for Dieting Success

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