FDA Warns Consumers About Counterfeit Weight Loss Drug Alli

The US Food and Drug Administration issued a warning to consumers on Monday about a counterfeit version of GlaxoSmithKline’s over-the-counter weight loss drug Alli. Currently, there is no evidence that the fake is being sold in legitimate retail stores, but reports have been received about online purchases.

GlaxoSmithKline director of communications, Malesia Dunn, has said that the company has so far received about 25 complaints since early December 2009, but the product is used by about 7.5 million people daily.

Alli is a reduced-dosage version of the drug Xenical that is approved for over-the-counter sales in the United States. The key ingredient is orlistat, however the counterfeit product contains sibutramine, which is the ingredient in another prescription weight-loss medication, Meridia by Abbott Laboratories. Physicians warn that sibutramine, a controlled substance that can react with other medications, should only be taken with a doctor’s oversight and is not approved for over the counter sales.

To spot the counterfeit product, the FDA gives consumer these warning signs:

• The counterfeit product is being sold in 60-milligram capsules as part of a 120-count refill kit.
• The outer packaging is missing a “lot” code and has an expiration date that includes the month,date, and year, as in the example 01192010. Alli’s expiration date just states the month and year in the form m/yy.
• The foil seal on the top of the authentic Alli reads “sealed for your protection” in white ink, while the counterfeit is plain.
• The capsule size of the fake is slightly larger and the content inside is powdery. Alli is more “pellet-like”.

For consumers that believe they have received one of the counterfeit Alli packages, the FDA and GlaxoSmithKline recommends contacting the FDA Office of Criminal Investigations at 800-551-3989 or online at www.fda.gov/OCI. Health care professionals and consumers are also encouraged to report adverse events that may be related to the use of a counterfeit product through the FDA’s MedWatch Program at 800-FDA-1088.

Alli, approved for use in 2007, is recommended for weight loss as part of a six-month program including diet and exercise. It should be taken up to three times a day with meals. It is designed to limit about 25% of the total absorption of fat taken in from food.

The FDA is currently conducting an investigation into the product because of reports of liver injury among users of weight loss drugs that contain orlistat. Consumers who experience jaundice, weakness, fatigue, or stomach pain should discontinue use and contact the FDA’s MedWatch Program listed above.

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