Sibutramine verwijderd van Amerikaanse marktNieuws - 11 okt. 2010
Sibutramine withdrawn from US market
The maker of the weight-loss drug sibutramine (Meridia, Abbott Laboratories) has agreed to withdraw it from the US market, following evidence of increased cardiovascular risk among patients taking the drug.
Sibutramine was approved in the USA in 1997 for use in patients with a body mass index (BMI) of at least 30 kg/m2 or for those with a BMI of at least 27 kg/m2 plus cardiovascular risk factors.
As recently reported, the European post-marketing SCOUT (Sibutramine Cardiovascular Outcomes) trial revealed nonfatal myocardial infarction (MI) or stroke, resuscitated cardiac arrest, or cardiovascular death rates of 11.4% among patients taking sibutramine versus 10.0% in the placebo group.
This significant 16% difference was driven by a 28% increase in nonfatal MI risk and a 36% increase in nonfatal stroke.
The US Food and Drug Administration (FDA) therefore requested that sibutramine's manufacturer, Abbott Laboratories, voluntarily withdrew the drug from the US market, to which the company has agreed.
"[Sibutramine's] continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke," said John Jenkins, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research.
"Physicians are advised to stop prescribing [sibutramine] to their patients and patients should stop taking this medication."
The European Medicines Agency withdrew the drug from use within the European Union in January 2010.