Anti-obesity treatment sibutramine withdrawn

22nd January 2010 — The licence for the anti-obesity pill sibutramine – also known as Reductil – has been withdrawn across Europe after evidence suggested that there is an increased risk of non-fatal heart attacks and strokes with the medication. The risks, regulators say, outweigh the weight loss benefits, which are modest and may not be sustained in the long term after treatment is stopped.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a bulletin to doctors advising them not to issue any new prescriptions for sibutramine, and to review treatment for patients already taking the medication.

Pharmacies are being asked to stop dispensing sibutramine.

Anyone currently taking sibutramine is being advised to see a GP to look at alternative treatments. The European Medicines Agency says people can stop taking the product at any time rather than waiting to see their doctor.

Sibutramine is in a group of medications called appetite suppressants. Taken as a tablet once a day, it was designed to work by making you feel less hungry, making dieting easier.
Sibutramine was first reviewed by the European Medicines Agency in 1999 and 2002, after concerns over its safety, especially cardiovascular side effects.

In 2002, Abbot Laboratories, which makes the product, was asked to start a detailed study to look at its safety against a placebo. 9,800 obese patients have been followed up over six years.
Preliminary data given to the regulators in October 2009 indicated sibutramine was associated with more cardiovascular problems than the dummy treatment.

The European suspension will stay in place until the company can identify a group of patients for whom sibutramine’s benefits clearly outweigh its risks.