Healthy Skepticism Library item: 1709

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Publication type: news

Italy suspends sales of sibutramine over adverse events
Reuters Health 2002 Mar 7

Full text:

FLORENCE, Italy (Reuters Health) – Italy’s Health Ministry has suspended the sale of weight-loss products containing sibutramine, an anti-obesity drug patented by Abbot Laboritories, following 50 reports of adverse events.

In Italy, Abbott sells the drug as Reductil and with co-marketing partners GlaxoSmithKline Plc and Bracco it also sells it as Reduxade and Ectiva.

All three products were immediately withdrawn from the market, the ministry said in a statement late on Wednesday, in the first such move by any country since the drug was first approved in 1997.

The ministry’s decision followed a report by Italy’s Pharmaceutical Commission recommending a suspension of sales.

“Based on 50 reports of adverse events during treatment, the Pharmaceutical Commission decided that the beneficial effects of the drug must be re-evaluated,” the statement said.

The commission did not immediately comment on its findings. The decision is expected to be reviewed by the European Medicines Evaluation Agency (EMEA), the European drug watchdog.

Sibutramine-based drugs have been available in the US market since 1997 and were approved for Italy in April 2001.

Abbott said on Thursday that it was working the Italian and European authorities to confrim the safety of sibutramine.

“Abbott continues to provide semi-annual safety updates to regulatory authorities throughout Europe to routinely monitor Reductil’s safety profile,” Laureen Cassidy, spokeswoman for the US-based company, told Reuters.

“Based on these updates there has been no substantial change to the risk-benefit profile of the drug,” she said.

Abbott, which markets the drug as Meridia in the United States, said that 8.6 million people have used sibutramine-based drugs since they were approved in 1997.

Still, it is not the first time that drug watchdogs have warned of negative side effects. Last December, Britain’s Drug and Therapeutics Bulletin, published by the Consumers’ Association, warned the weight-loss drug had limited benefits and “unwanted” side effects.

The Bulletin said unwanted effects can include raised heart rates and blood pressure, both of which need to be monitored.

It added that the drug should not be used in several conditions that often accompany obesity, such as coronary artery disease, congestive heart failure and high blood pressure.