Saturday, July 10, 2010

FDA: Counterfeit Alli Contains 3 Times Daily Dose

The U.S. Food and Drug Administration is announcing that recently confiscated Counterfeit pills of the diet drug Alli contain up to three times of an active ingredient, which may be harmful to consumers.

Earlier this month, the FDA warned consumers about the counterfeit Alli pills circulating on the Internet and for sale in online auction sites. Alli is the brand name for the drug orlistat, but the counterfeit drugs being passed off as Alli contain a different stimulant drug, sibutramine.

The bogus drugs discovered were counterfeits of Alli 60 mg capsules sold in 120-count refill packs, officials said.

Alli is an FDA-approved over-the-counter weight loss drug made by GlaxoSmithKline.

Following laboratory testing, the FDA now has determined that the counterfeit Alli pills contain up to three times the usual daily dose of sibutramine if they are following the dosing instructions for Alli.

According to the FDA, that much sibutramine may cause health individuals to develop anxiety, nausea, heart palpitations, accelerated heart beat (tachycardia), insomnia, and increased blood pressure.

Also, such high levels of sibutramine can be fatal for patients with histories of cardiovascular disease and can cause high blood pressure, stroke, and heart attack.

Consumers first began reporting their suspicions of the counterfeit Alli to GlaxoSmithKline in early December 2009, officials said.

The bogus Alli product looks similar to the authentic product, but there are a few notable differences:

• Outer cardboard packaging missing a “Lot” code;
• Expiration date that includes the month, day, and year (e.g., 06162010); authentic Alli expiration date includes only the month and year (e.g.,: 05/12);
• Packaging in a plastic bottle that has a slightly taller and wider cap with coarser ribbing than the genuine product;
• Plain foil inner safety seal under the plastic cap without any printed words; the authentic product seal is printed with “SEALED for YOUR PROTECTION”;
• Contains larger capsules with a white powder, instead of small white pellets.

Secure Pharma Chain Blog encourages all consumers to only purchase pharmaceuticals through internet sites that are affiliated with a reputable pharmacy or that are sanctioned by the National Boards of Pharmacy through their VIPP accreditation. Never buy from an internet site that does not require a prescription from your individual physician.

In addition Secure Pharma Chain Blog encourages all members of the pharmaceutical supply chain use authentication technologies to verify and secure their inventories to protect both their brand and all health care consumers.

To learn more about pharmaceutical supply chain anti-counterfeiting technologies, visit:

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