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FDA warns of counterfeit Alli

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FDA warns of counterfeit Alli

Posted Monday, February 1, 2010

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The Food and Drug Administration (FDA) is warning the public about a counterfeit version of the weight-loss drug Alli 60 mg capsules (120 count refill pack) being sold over the Internet, particularly at online auction sites.

The counterfeit product is illegal and unsafe. FDA advises people who believe that they have a counterfeit product not to use the drug. There is no evidence at this time that the counterfeit Alli product has been sold in retail stores.

How to Recognize the Counterfeit Alli

The counterfeit Alli looks similar to the authentic product, with a few notable differences (see photos). The counterfeit Alli has

  • a missing LOT code on the outer cardboard packaging
  • an expiration date that includes a MONTH, DAY, and YEAR—the expiration date of the real Alli only contains a MONTH and a YEAR
  • a plain foil for the inner safety seal without any words on it—the safety seal of the real Alli has the words “SEALED FOR YOUR PROTECTION” prominently printed on it.
  • large capsules with white powder, as opposed to small white pellets found in the real Alli
  • a slightly taller plastic bottle with a wider cap and coarser ribbing on the cap than what is seen with the real Alli
Dangers of Counterfeit Alli

Alli is an FDA-approved, over-the-counter weight-loss drug that contains orlistat as its active ingredient. The counterfeit version of Alli does not contain orlistat; instead it is made with varying amounts of sibutramine, a stimulant drug.

Although sibutramine is the active ingredient in another FDA-approved prescription weight-loss drug, it is only to be used in specific doses and under the supervision of a physician.

FDA first warned consumers about the counterfeit product on Jan. 18, 2010, based on preliminary laboratory tests that revealed the counterfeit version contained sibutramine and not orlistat. Since that time, FDA lab tests on the counterfeit product show that people may be taking three times the usual daily dose (and twice the recommended maximum dose) of sibutramine if they are following the dosing directions for Alli.

This excessive amount of sibutramine is dangerous to people who have a history of cardiovascular disease and can lead to

  • elevated blood pressure
  • stroke
  • heart attack
Even healthy people who take this much sibutramine can experience
  • anxiety
  • nausea
  • heart palpitations
  • a racing heart
  • insomnia
  • small increases in blood pressure
FDA Recommendations

Check to make sure you are not taking counterfeit Alli. If you think you might have the counterfeit product:

  • stop taking the drug
  • contact your health care professional if you are experiencing more than mild side effects, especially if you have a history of cardiovascular disease
  • call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989 or by visiting the OCI Web site; you may also contact Alli’s maker, GlaxoSmithKline at 800-671-2554
FDA encourages people to report any unexpected side effects that may be related to the use of the counterfeit product to FDA's MedWatch Adverse Event Reporting program either online, by regular mail, by fax, or by phone.
  • Online
  • Regular Mail: Use postage-paid, pre-addressed FDA form 3500
  • Fax: 1-800-FDA-0178
  • Phone: 1-800-332-1088
 
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