FDA: Counterfeit orlistat has risky sibutramine amount

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FDA: Counterfeit orlistat has risky sibutramine amount

Generics/News | Posted 22/02/2010 0 Post your comment

As reported by Scrip, the US FDA has re-iterated its concerns about a counterfeit version of GlaxoSmithKline's Alli (orlistat), which contains varying degrees of sibutramine rather than the correct active ingredient.

On 25 January 2010, the FDA warned the public about a counterfeit version of the weight-loss drug Alli 60 mg capsules (120 count refill pack) being sold over the Internet, particularly at online auction sites. “The counterfeit product is illegal and unsafe. FDA advises people who believe that they have a counterfeit product not to use the drug. There is no evidence at this time that the counterfeit Alli product has been sold in retail stores”, the FDA writes.

It has warned consumers that laboratory tests indicate that consumers taking the counterfeit product may be ingesting three times the usual daily dose (or twice the recommended maximum dose) of sibutramine if they are following the dosing directions for Alli.

"The amount of sibutramine in the counterfeit Alli poses a serious risk to some individuals", Dr Janet Woodcock, Head of the FDA's drug centre, said on a conference call. She said that healthy people who take twice or three times the normal amount of sibutramine can experience anxiety, nausea, heart palpitations, tachycardia, insomnia and small increases in blood pressure. This excessive amount of the drug is dangerous to patients with a history of cardiovascular disease, and can lead to elevated blood pressure, stroke or heart attack, the regulators stated.

As of 25 January 2010, FDA officials told consumers to discard immediately any Alli product that they believe to be counterfeit. Although sibutramine is approved in the US and the EU for the treatment of obesity (marketed as Meridia in the US by Abbott), both the FDA and the European Medicines Agency (EMA) have been reviewing the drug's safety profile in light of concerns that it might increase cardiovascular risk. Indeed, Abbott has just announced that it is to suspend European sales of the drug, sold as Reductil.

The counterfeit products, sold as Alli 60mg capsules (120-count refill pack), are being sold over the internet, particularly at online auction sites. The FDA has posted links to photographs of GlaxoSmithKline's approved versions and the counterfeits.

The FDA and EMA action has also prompted the UK medicines regulator, the MHRA, to issue a warning over potential sales of counterfeit Alli online. The agency has recommended customers check for a lot code, foil inner safety seal, capsules branding with the word 'Alli' and ensure websites include the green cross logo of the Royal Pharmaceutical Society of Great Britain (RPSGB). The product is also only available in 42 and 84, and not 120, pack sizes in the UK.

References:

Nancy Faigen. Counterfeit Alli: lab tests show three times the normal dose of sibutramine. Scrip News. 2010 January 26.

Warning: Counterfeit Alli. FDA News Release. 2010 January 25.

Source: Scrip News; FDA News Release