FDA Warning Over Counterfeit Diet Drug
Issuing a consumer warning Monday, the US Food and Drug Administration (FDA) says counterfeit versions of GlaxoSmithKline’s Alli 60-mg capsules, a diet drug being sold over the Internet could be dangerous.
The genuine Alli sold over-the-counter in a variety of retail stores comes in 60- mg. capsules sold in a 120 count refill kit, with over 7.5 million people using the product daily. Last month, GlaxoSmithKline began receiving complaints about the product purchased online from auction sites like eBay.
Malesia Dunn, Glaxo’s Director of Communications for its consumer health-care division said, 25 complaints had been received regarding the counterfeit Alli.
Counterfeit Alli, preliminary laboratory tests reveal contain sibutramine, a controlled substance that is the active ingredient in Abbott Laboratories’ prescription weight-loss drug Meridia, instead of Olistat to be found in the genuine product. Sibutramine’s interaction with certain other medications can be dangerous.
According to GlaxoSmithKline, Alli is to be taken thrice a day, while Meridia is taken once daily. As well, the company said Alli should be purchased from reputable retail stores or from branded online web sites.
The following clues will help you determine, whether the Alli you have purchased is counterfeit or not:
· Genuine Alli capsules come in the form of small, white pellets, as opposed to the fake capsule which is large and powdery.
· Fake Alli will not have any lot number on the packaging.
· Counterfeit products have an expiration date that includes the month, day and year, while Glaxo’s Alli has just the month and the year e. g. 5/12.
· The inner foil safety seal for genuine Alli products is printed with the words SEALED FOR YOUR PROTECTION in white ink, not the case for fake products.
Consumers believing they are in receipt of counterfeit Alli products, should call 800-551-3989 to contact the FDA’s Office of Criminal Investigations or visit its website at www. fda. gov/OCI.
The only over-the-counter weight loss product to receive FDA approval, Alli, approved two years ago is a weaker version of Xenical, a prescription weight-loss drug marketed by Roche Holding AG.
Alli designed help people lose weight as part of a six-month programme that includes diet and exercise, is taken thrice a day with meals containing fat, limits about 25% of the total absorption of fat taken in from food. The excreted fat can cause unpleasant gastrointestinal side effects in some people.
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