Counterfeit Alli Pills Contain 3x Daily Dose
Counterfeit pills of the diet drug Alli contain up to three times of an active ingredient, which may be harmful to consumers, the Food and Drug Administration said.
Earlier this month, the FDA warned consumers about fake 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 recalled pills were 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 PLC.
Potentially Deadly Overdoses Possible
The FDA now says further laboratory testing of samples of the counterfeit Alli pills has determined the tablets contain up to three times the usual daily dose of sibutramine if they are following the dosing instructions for Alli. That much sibutramine may cause health individuals to develop anxiety, nausea, heart palpitations, accelerated heart beat (tachycardia), insomnia, and increased blood pressure, the FDA said.
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.
Alli and a related drug, Xenical, are now being investigated by the FDA for possible links to liver failure and liver disease. From 1999 through October 2008, the FDA said it received 32 such reports from users of the two drugs, including six cases of liver failure and 27 cases in which patients required hospital treatment.
Consumers first reported counterfeit Alli to the company in early December 2009, officials said.
How to Spot Counterfeit Alli
The counterfeit Alli product looks similar to the authentic product, but there are a few notable differences, the FDA said. The counterfeit Alli has:
• 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.
Related posts:
- Asurion Recalls Counterfeit BlackBerry(r)-branded Batteries Due to Burn and Fire Hazards The counterfeit batteries can overheat, posing burn and fire hazards....
- Tamiflu: Counterfeit Product Sold on Internet Audience: Consumers, Pharmacists Fraudulent product is dangerous to patients allergic...
- Orlistat (marketed as Alli and Xenical): Labeling Change Audience: Family Practice healthcare professionals, patients/consumers FDA notified healthcare professionals...
- Meridia, Alli and Xenical: Popular Diet Drugs in the Safety Spotlight Diet drugs taken by millions of people looking to shed...
- FDA Warns of Counterfeit Alli Diet Pills Consumers are being warned about fake and potentially harmful versions...
