A new pill to help the obese lose weight, approved for use in the NHS by the government's national institute for clinical excellence, was yesterday withdrawn from sale in Italy because of 50 reports of problems, including the deaths of two women.
The pill is sibutramine, which is manufactured by Knoll and sold in the UK under the brand name Reductil.
The drug works by suppressing the appetite, and was approved by Nice last October. Doctors can prescribe it to patients who are seriously overweight as part of a strategy to tackle their problem that would include a calorie-controlled diet.
Two months later, however, the Consumers' Association's Drug and Therapeutics Bul letin warned that the pill could be dangerous.
The bulletin said that there could be dangerous side-effects, such as raised heart rates and blood pressure.
Italy's health ministry ordered a halt to the sale of sibutramine after the deaths of two women, aged 28 and 45, who were being treated with it for obesity.
The ministry has also received reports of serious side- effects, including high blood pressure, accelerated heart-beat, anxiety and gastrointestinal problems, in another 50 cases.
The abrupt decision by the Italian government may force a rethink in the UK.
Three drugs that contain sibutramine have been withdrawn - Reductil (which in Italy is sold by Abbott), Reduxade and Ectiva. The latter two are sold jointly by Abbott, GlaxoSmithKline, and the Italian firm Bracco. It is the first time since 1997 that any drug has been withdrawn in Italy.
The manufacturers said yesterday that they were collaborating with the Italian pharmaceuticals commission to seek to confirm the safety of the product, which has been used by more than 8.6m people since 1997 and is registered in more than 70 countries.