The Pharmaceutical Journal
Vol 268 No 7190 p385-391
23 March 2002

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Italy suspends sibutramine licence

A decision by the Italian ministry of health to suspend the marketing authorisation for products containing sibutramine has led to concern over the drug's safety.

The decision follows reports of the deaths of two women being treated with sibutramine for obesity. Abbott Laboratories, manufacturer of sibutramine (Reductil), has been quick to point out that the action is specific to Italy and that the drug has not actually been withdrawn.

A spokesman for the Medicines Control Agency said: "The MCA and the Committee on Safety of Medicines are reviewing the data that led to the regulatory action in Italy. Patients currently treated with sibutramine can continue to take their medicines as usual. However, if they are unwell or concerned they should speak to their doctor."

Up to 13 March 2002, the MCA had received 212 reports of suspected adverse reactions associated with sibutramine via the yellow card scheme in the United Kingdom. "Of these reports, 93 were considered serious, including two reports where the suspected adverse reaction had a fatal outcome. In both these fatal cases the patients had underlying medical conditions that may have contributed to their death," the MCA says.

It adds that the reactions with sibutramine most commonly reported through the yellow card scheme are headache, hypertension, tachycardia, insomnia, dizziness, anxiety, sweating and minor gastro-intestinal symptoms.

All these are recognised reactions and are listed in the summary of product characteristics.