Fake Alli delivers 'dangerous' dose of sibutramine

People who take counterfeit versions of GlaxoSmithKline's weight loss drug Alli risk exposing themselves to three-times the daily recommended dose of sibutramine, according to an update from the US Food and Drug Administration.

"Additional FDA laboratory tests on the counterfeit product show that people may be taking three times the usual daily dose - or twice the recommended maximum dose - of sibutramine if they are following the dosing directions for Alli," according to the FDA's MedWatch announcement.

The agency goes on to note that healthy people who take this much sibutramine can experience anxiety, nausea, heart palpitations, tachycardia, insomnia, and small increases in blood pressure.

Moreover, "this excessive amount of sibutramine is dangerous to people who have a history of cardiovascular disease, and can lead to elevated blood pressure, stroke, or heart attack."

The announcement comes as concerns over the safety of legitimate sibutramine grow, with a European Medicines Agency (EMA) advisory panel recommending a suspension of the manufacturing license for all products based on the ingredient after seeing an increased rate of serious cardiovascular side effects among people taking the drug.

The drug's manufacturer, Abbott Laboratories, has suspended sales to comply with the recommendation. Abbott sells the drug as Reductil, Reduxade and Zelium in Europe and as Meridia in the USA.

The FDA, however,  has stopped short of suspending products based on sibutramine, but has added new warnings indicating that the drug "should not be used in patients with heart failure, hypertension, irregular heart beats and other problems."

Last week, the FDA issued a warning to consumers not to purchase Alli over the Internet after GSK said it had received a number of reports of consumers purchasing the fake in December 2009.

Genuine Alli contains a compound called orlistat that works by binding fat in the gastrointestinal tract so that it is not absorbed by the body.

Sibutramine is a schedule IV controlled substance and acts by altering neurotransmitters in the brain to reduce the craving for food. It has a number of side effects and serious interactions with other drugs which make it essential for treatment to be carried out under a physician's supervision.


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