AR: FDA is warning the public about a potentially dangerous counterfeit version of the weight-loss drug Alli (orlistat). To date, all the counterfeits seem to have been sold on the internet. The genuine version of Alli, which is approved by FDA for over-the-counter use, contains a substance that prevents the absorption of fats from the diet. The counterfeit Alli contains the stimulant drug sibutramine, which can cause potentially fatal side effects, particularly in people with a history of heart disease.
MB: Sibutramine is an ingredient in an approved weight loss drug, but it's available only by prescription and must be used under the supervision of a physician. FDA tests have shown that people taking the counterfeit Alli in the dose specified on the package may be receiving several times the usual daily dose of sibutramine.
AR: People taking Alli should check to be sure they don't have the counterfeit version. Here are some things to look for:
• The counterfeit has a missing lot number on the outer cardboard packaging;
• The counterfeit has an expiration date that includes a month, day and year - the real Alli only has a month and year;
• The foil safety seal on the mouth of the counterfeit bottle has no writing - the seal on the real Alli says "Sealed for your protection";
• The counterfeit capsules contain a white powder - the real capsules contain small white pellets;
• The counterfeit version is packaged in a plastic bottle that has a slightly taller and wider cap than the real Alli, with coarser ribbing.
MB: People who think they may have the counterfeit product should stop using it immediately and contact FDA's Office of Criminal Investigations at 1-800-551-3989. Anyone having side effects such as nausea, insomnia and an unusually fast or irregular heartbeat, should contact their healthcare professional. And that's especially important for people with a history of heart disease.
标题
Warning on Counterfeit Alli (FDA)
视频介绍
FDA Patient Safety News - March, 2010 - Show #96
FDA is warning the public about a potentially dangerous counterfeit version of the weight-loss drug Alli (orlistat).
Speaker #1: Anita Rayner (AR), Associate Director, Policy & Communications, U.S. Food and Drug Administration
Speaker #2: Mark Barnett (MB), Assistant Director, Education & Communication, U.S. Food and Drug Administration








