FDA Says Beware of Fake Alli

The U.S. Food and Drug Administration (FDA) is warning consumers that a counterfeit version of the popular weight loss medication Alli contains a potentially harmful ingredient.

Alli (60 mg orlistat) is an FDA approved weight loss product available without a prescription over-the-counter.

The manufacturer, GlaxoSmithKline (GSK), began receiving reports of suspected counterfeit Alli in early December 2009 from consumers who bought the product over the internet. Laboratory testing of the suspicious product by GSK found that the samples did not contain orlistat, the active ingredient in Alli, but instead contained sibutramine.

Sibutramine (Meridia) is an appetite suppressant approved by the FDA for weight loss, but only available by prescription for obese patients under the supervision of a physician. Not only does sibutramine have a long list of potential side effects, dangerous drug interactions may result from using the drug in combination with other prescription and nonprescription medications, vitamins, nutritional supplements and herbal products. In November of 2009, the FDA notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events such as heart attack, stroke, resuscitated cardiac arrest or death than patients using a placebo.

Consumers are advised the counterfeit Alli product looks similar to the authentic product, except 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.

Consumers who believe they have received counterfeit Alli are asked to contact the FDA’s Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).

Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these counterfeit products to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

If you or a loved one has suffered a dangerous drug interaction or harmful side effects of over-the-counter or prescription medication, contact Napoli Bern Ripka, LLP at 888-529-4669 to discuss your options for filing a claim and recovering compensation for your medical expenses, lost wages and pain and suffering.