The Food and Drug Administration (FDA) has updated its warning to the public about a counterfeit version of the over-the-counter weight loss drug Alli 60 mg capsules (120-count refill pack) that is being sold over the Internet, particularly at online auction sites. The new warning includes information from additional laboratory tests that shows that some capsules contain as much as three times the usual daily dose (or twice the recommended maximum dose) of sibutramine, an FDA-approved ingredient for weight loss that can be life-threatening to some populations. 

Alli is an FDA-approved medication for weight management. Its active ingredient is orlistat. The counterfeit version of Alli does not contain orlistat, but does contain varying amounts of sibutramine. Sibutramine is a stimulant that is only to be used in specific doses and under the supervision of a physician. Healthy people who take these elevated levels of sibutramine can experience anxiety, nausea, heart palpitations, tachycardia (a racing heart), insomnia, and small increases in blood pressure.

The excessive amount of sibutramine in the counterfeit pills is dangerous to people who have a history of cardiovascular disease and can lead to elevated blood pressure, stroke, or heart attacks.

Last week the FDA also issued a warning to health care professionals about prescribing the weight loss prescription drug Meridia to people with cardiovascular issues because of a risk of serious and life-threatening adverse reactions. Meridia, an FDA-approved drug for weight management in obese people, contains sibutramine.  

The FDA calls the counterfeit Alli product “illegal and unsafe,” and urges everyone to check and be sure they are not taking counterfeit Alli. If they suspect they are taking the counterfeit product they should stop taking it at once and dispose of it. The counterfeit product can be identified by the following:

• Outer cardboard packaging missing a “lot” code.
• Expiration date that includes the month, day and year; authentic Alli expiration date includes only the month and year.
• 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 are taking the counterfeit Alli  are also advised to contact the FDA’s Office of Criminal Investigations at 800-551-3989, or visit the OCI Web site. http://www.fda.gov/CriminalInvestigations/OfficeofCriminalInvestigations/default.htm Anyone who is experiencing more than mild side effects, especially if they have a history of cardiovascular disease, should contact their healthcare professional.