Alerts
Orlistat (Alli) -- Counterfeit Capsules
January 26, 2010
FDA warned healthcare professionals and consumers about counterfeit Alli (orlistat) 60 mg capsules. The counterfeit presentation (120 count refill pack) contains sibutramine instead of the active ingredient, orlistat. FDA laboratory testing found patients following the dosing directions for Alli may be consuming up to two times the recommended maximum daily dose of sibutramine. The counterfeit version is being sold and distributed over the internet according to GlaxoSmithKline, the manufacturer of Alli. There are no reports of counterfeit product being sold in other settings.
Sibutramine is a prescription weight loss medication and is not appropriate for certain patient populations, especially patients with a history of cardiovascular disease. Sibutramine may interact with other medications and should not be used without physician supervision.
FDA advises consumers to check to make sure they are not taking counterfeit Alli. Counterfeit or suspected counterfeit products should not be taken. Patients experiencing side effects such as insomnia, anxiety, or heart palpitations or patients with a history of cardiovascular disease taking the counterfeit product should contact their primary care provider.
The differences in the counterfeit capsules compared to the authentic Alli 60-mg capsules are listed below.
- Counterfeit capsules contain white powder instead of small, white drug pellets.
- Counterfeit capsules are supplied in a slightly taller plastic bottle with a slightly wider neck. The ribbing around the opening is coarser with the counterfeit version.
- The safety seal of the counterfeit bottles has no writing. The authentic product contains “SEALED for YOUR PROTECTION” printed on the safety seal.
- The outer packaging of the counterfeit version is missing a lot number and lists the expiration date as month, day, and year. The authentic version includes a lot number and lists the expiration as month and year.
If a healthcare professional or consumer suspects counterfeit drug supply, contact the FDA’s Office of Criminal Investigations by phone at 800-551-3989 or online at www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm. For any adverse events related to the consumption of the counterfeit version, contact the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by calling 800-332-1088 or online at www.fda.gov/MedWatch/report.htm.
Additional information is available at the following links:
- MedWatch Alert
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197862.htm - FDA News Release
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197857.htm - FDA Updated Public Health Alert
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm198519.htm - FDA Consumer Updates: Counterfeit Alli
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm198557.htm
Updated
January 26, 2010; January 19, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.
