Bad day for slimming pill sibutramine, as EMEA calls for drug's withdrawal and US FDA for 'black box' warning

The weight loss drug sibutramine suffered a double whammy yesterday, after the European Medicines Agency (EMEA) called for the suspension of the marketing authorization of the products containing the compound and the USA's Food and Drug Administration stated that the drug should carry a 'black box' warning due to an increased risk of stroke and heart attack in patients with a history of cardiovascular disease.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) concluded that the risks of these medicines are greater than their benefits and recommended the suspension of marketing authorisations for these medicines across the European Union.

Sibutramine-containing medicines are authorised as Reductil, Reduxade and Zelium and other trade names in the European Union. They are used to promote weight-loss in obese patients and in overweight patients who also have other risk factors such as type-2 diabetes or dyslipidemia (abnormal levels of fat in the blood), together with diet and exercise.  The Agency said that doctors should no longer prescribe, and pharmacists should no longer dispense the medicine.