FDA Warns Consumers About Tainted Weight Loss Pills
Agency seeks recall of products that pose serious health
riskshttp://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html
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.htmRegular 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.
For drug safety information, read: FDA's
Drug Safety Initiative
