Fda

Tainted Weight Loss Pills Flagged as Health Risks
On Dec. 22, 2008, the Food and Drug Administration (FDA) alerted consumers not to buy or use
more than 25 different weight-loss pill products because the products may be harmful to their
health. FDA has recently expanded this alert.

Which products have been cited?
For the latest list of tainted weight loss products, visit
www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html
Why did FDA act against these products?
These products contain undeclared, active pharmaceutical ingredients that may put consumers'
health at risk. Some of the amounts of active pharmaceutical ingredients far exceed FDA-
recommended levels.
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 FDA, are illegal, and may be
potentially harmful to unsuspecting consumers.
What undeclared ingredients were found?
An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these
products include
- sibutramine, a controlled substance that can cause high blood pressure, seizures, abnormally
rapid heart rate (tachycardia), palpitations, heart attack or stroke. It can also interact with other
medications and increase patients' risk of unexpected bad side effects (adverse reactions).
Sibutramine's safety has also not been established in pregnant and lactating women, or in children
younger than 16.
- rimonabant, a drug not approved for marketing in the United States, has been associated with
increased risk of depression and suicidal thoughts. In Europe, where it is approved, rimonabant
has been linked to five deaths and 720 adverse reactions over the last two years.
- phenytoin, an anti-seizure medication
- phenolphthalein, a solution used in chemical experiments that is a suspected cancer-causing
agent
Where are these products sold?
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.
Is FDA taking further action?
The agency is currently seeking product recalls. FDA may take additional enforcement steps, such
as issuing warning letters or initiating seizures, injunctions, or criminal charges.
Tips for consumers
If you use any of these weight-loss products, stop taking them and consult your health care
professional immediately.
Seek guidance from a health care professional before purchasing weight-loss products.
Report serious adverse reactions or product quality problems to FDA's MedWatch Adverse Event
Reporting program at www.fda.gov/MedWatch/report.htm
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer),
which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions
at www.fda.gov/consumer/consumerenews.html.

For More Information
Protect Your Health
Joint FDA/WebMD resource www.webmd.com/fda
FDA Press Release www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html
Information for Consumers www.fda.gov/cder/consumerinfo/weight_loss_products.htm
FDA MedWatch www.fda.gov/MedWatch/report.htm
Updated: January 9, 2009

Source: http://www.adiitalia.net/documenti/news/FDA.pdf