FDA Warns Consumers About Tainted Weight Loss Pills

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html
FDA News

FOR IMMEDIATE RELEASE
December 22, 2008


Media Inquiries:
Rita Chappelle, 240-753-8603
Consumer Inquiries:
888-INFO-FDA

FDA Warns Consumers About Tainted Weight Loss Pills
Agency seeks recall of products that pose serious health risks

The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers’ health at risk.

The tainted weight loss products are:

Fatloss Slimming


2 Day Diet


3x Slimming Power

Japan Lingzhi 24 Hours Diet


5x Imelda Perfect Slimming


3 Day Diet

7 Day Herbal Slim


8 Factor Diet


7 Diet Day/Night Formula

999 Fitness Essence


Extrim Plus


GMP

Imelda Perfect Slim


Lida DaiDaihua


Miaozi Slim Capsules

Perfect Slim


Perfect Slim 5x


Phyto Shape

ProSlim Plus


Royal Slimming Formula


Slim 3 in 1

Slim Express 360


Slimtech


Somotrim

Superslim


TripleSlim


Zhen de Shou

Venom Hyperdrive 3.0







An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers' health at risk.

These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.

The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss 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 their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”

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 health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.

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: www.fda.gov/MedWatch/report.htm

* 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

Information for consumers can be found at:

http://www.fda.gov/cder/consumerinfo/weight_loss_products.htm

Consumer Directed Questions and Answers about FDA’s Initiative Against Contaminated Weight Loss Products

FDA has developed these questions and answers (Q & A’s) to help consumers, health care practitioners, and the general public understand FDA’s actions regarding weight loss products contaminated with various prescription drugs and chemicals. Many of these products are marketed as dietary supplements. Unfortunately, FDA cannot test and identify all weight loss products on the market that have potentially harmful contaminants in order to assure their safety. Enforcement actions and consumer advisories for unapproved products only cover a small fraction of the potentially hazardous weight loss products marketed to consumers on the internet and at some retail establishments.

1. What undeclared drugs and/or chemicals are contained in the weight loss products associated with this action?

Laboratory tests revealed the presence of sibutramine, rimonabant, phenytoin, and phenolphthalein. A summary of our findings are below:

Undeclared Drug Product(s) Name>

Sibutramine


2 Day Diet
3 Day Diet
3x Slimming Power
5x Imelda Perfect Slimming
7 Diet Day/Night Formula
7 Day Herbal Slim
8 Factor Diet
24 Hours Diet
999 Fitness Essence
Extrim Plus
Fatloss Slimming
GMP
Imelda Perfect Slim
Lida DaiDaihua
Miaozi Slim Capsules
Perfect Slim
Perfect Slim 5x
ProSlim Plus
Royal Slimming Formula
Slim 3 in 1
Slim Express 360
Slim Tech
Somotrim
Superslim
Triple Slim
Venom Hyperdrive 3.0
Zhen de Shou

Rimonabant


Phyto Shape

Phenytoin (trace)


3x Slimming Power
Extrim Plus

Phenolphthalein


8 Factor Diet
24 Hours Diet
Fatloss Slimming
Imelda Perfect Slim
Perfect Slim 5x
Royal Slimming Formula
Superslim
Zhen de Shou



2. What action is FDA taking regarding these tainted weight loss products?

FDA is taking action to help ensure that these products and other products containing undeclared prescription ingredients are removed from the marketplace. FDA has inspected a number of firms associated with the sale of these products and is currently seeking recalls of the products. Based on these inspections and the firms’ responses to recall requests, FDA may take additional enforcement steps to include warning letters, seizure, injunction, or criminal charges.

3. What is sibutramine and what are the associated risks?

Sibutramine is a Schedule IV controlled substance and the active pharmaceutical ingredient in Meridia, an approved prescription drug to treat obesity.

Some of the identified products recommend taking more than 3 times the recommended daily dosage of sibutramine. Because of this, even consumers without a history of health problems that take these high doses of sibutramine may suffer serious adverse effects if they take these products, such as increased blood pressure, tachycardia, palpitations, and seizure.

Populations who would be at increased risk of serious adverse health effects from consuming a standard dose of sibutramine include:

* Patients with a history of hypertension, especially those with uncontrolled or poorly controlled hypertension.
* Patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
* Patients with narrow angle glaucoma.
* Patients with a history of seizure.
* Patients predisposed to bleeding events and those taking concomitant medications known to affect hemostasis or platelet function.
* Patients with severe hepatic dysfunction.
* Patients concurrently taking the following medications:
o Sumatriptan
o Dihydroergotamine
o Dextromethorphan
o Meperidine,
o Pentazocine
o Fentanyl
o Lithium
o Tryptophan
o MAO inhibitors

4. What is rimonabant and what are the associated risks?

Rimonabant is the active pharmaceutical ingredient in Zimulti which has not been approved in the United States. In Europe the drug is known as Acomplia.

In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects—seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. In June of 2008, the Medicines and Healthcare Products Regulatory Agency of the United Kingdom linked rimonabant to 5 deaths and 720 adverse reactions over the past two years. In October, the European Medicines Agency recommended that marketing and sales of Accomplia be suspended due to safety concerns.

5. What is phenolphthalein and what are the associated risks?

Phenolphthalein was an ingredient in some Over-the-Counter laxative products until 1999 when the FDA reclassified the drug as “not generally recognized as safe and effective” after studies indicated that phenolphthalein presented a potential carcinogenic risk. Phenolphthalein has also been found to be genotoxic in that it can damage or cause mutations to DNA.

6. What is phenytoin and what are the associated risks?

Phenytoin is the active pharmaceutical ingredient in Dilantin, an approved anti-seizure medication. Because there were trace amounts of this drug in some of these products, the risk was not assessed. However, these products could pose a risk to consumers who are allergic or hypersensitive to phenytoin.

7. Who are the manufacturers of these products?

Many of these products do not list the manufacturer on the label or in the advertisements. However, most of the products appear to have been manufactured in China.

8. Does FDA regulate these products?

Although some of the identified products are marketed as “dietary supplements”, all of these products should have been submitted to the FDA for approval prior to marketing. Regulatory requirements for dietary supplements differ from those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that its products are safe before they are marketed. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.

Manufacturers must make sure that product label information is truthful and not misleading. However, products which contain an ingredient that has been approved as a new drug such as sibutramine or an ingredient that does not supplement the diet are not considered to be dietary supplements. Consequently these products should also have been submitted to FDA for approval prior to their marketing.

9. Will there be recalls?

It is anticipated that several of these products will be recalled. Recalls and instructions for returns can be found at: http://www.fda.gov/opacom/7alerts.html.

10. Are there more contaminated products like these on the market?

More and more products tainted with prescription drugs, including drugs for erectile dysfunction, diabetes, and obesity, are finding their way into the U.S. marketplace. Many are labeled as dietary supplements or supplements. FDA takes this escalating issue very seriously, and is committed to doing all that it can to identify and remove these dangerous products from the market. However, unfortunately, it is not possible for FDA to test and identify all tainted products.

11. What can consumers do to help protect themselves from harm?

Consult with your health care professional before taking dietary supplements to treat obesity or other diseases. All consumers should be familiar with the following signs of health fraud:

* Promises of an "easy" fix for problems like excess weight, hair loss, or impotency.
* Claims such as "scientific breakthrough," "miraculous cure," "secret ingredient," and "ancient remedy."
* Impressive-sounding terms, such as "hunger stimulation point" and "thermogenesis" for a weight loss product.
* Claims that the product is safe because it is "natural."
* Undocumented case histories or personal testimonials by consumers or doctors claiming amazing results.
* Promises of no-risk, money-back guarantees.


To learn more about FDA’s initiative against unapproved drugs read FDA’s Compliance Policy Guide here:

http://www.fda.gov/cder/Guidance/6911fnl.htm.

For drug safety information, read: FDA's Drug Safety Initiative

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MEDICAL RECALLS:

http://www.fda.gov/cber/recalls.htm