E-drug: FYI: Italy suspends sales of sibutramine over adverse events
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Italy suspends sales of sibutramine over adverse events
[Copied as fair use. BS]
Last Updated: 2002-03-07 11:47:59 EST (Reuters Health)
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All three products were immediately withdrawn from the market, the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.
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