FDA Recall - recognize any names?

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FDA Warns Consumers About Tainted Weight Loss Pills

2008-12-23 - Food and Drug Administration (FDA)

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

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.