Drugs & Adverse Effects / Beware of Meridia -- Italy Already Pulled it Off the Market

Italy's health minister Girolamo Sirchia has suspended sales of anti-obesity drugs containing sibutramine after 50 reports of adverse events among people taking the medicines.

The decision follows a report from the General Directorate for the Evaluation of Drugs and Pharmacovigilance. All drugs that contain sibutramine, including Abbott's anti-obesity drug Reductil (called Meridia in the US), have been withdrawn from the market.

"Based on 50 reports of adverse events during treatment, the CUF (Drugs Committee) decided that the beneficial effects of the drug must be re-evaluated."

Sibutramine-based drugs have been on the Italian market since April 2001.

The ministry advises people currently using sibutramine to stop taking the medicines and seek advice from their doctor.

Dr. Eugene Sun, the vice president for pharmaceutical development at Abbott reported that the company has received reports of 32 deaths in people who were taking sibutramine, with 28 in the US, two in Italy, one in Switzerland, and one in South Africa.

About 20,000 Meridia prescriptions are filled in the US each week, according to the FDA. Abbott said that 8.5 million people worldwide have taken the drug.

The drug was approved for use in the US in 1997. A risk of increased blood pressure and heart rate have been reported in some patients taking it.

Reuters Florence March 7, 2002