Just 18 months after the UK's Department of Health declared that the slimming drug Reductil (sibutramine) was safe, fresh evidence from the USA suggests that they may need to think again.
The new concern is the same as the old one - that the drug can trigger fatal heart attacks. The UK government was aware of the possible association when it gave Reductil a clean bill of health in March 2002, but said that the two deaths linked to the drug at the time were most likely the result of specific medical conditions.
But now, Public Citizen, an American consumer group, has uncovered a further 30 cardiovascular deaths linked to the drug since the previous alert - also in March 2002 - when it claimed the drug had caused 19 deaths in the US.
Up to the time of the UK government review, Reductil - marketed in the States as Meridia - had 200 adverse reactions reported for it, 93 of which were considered dangerous, including the two deaths.
Similar figures have been reported in Italy, where the drug is now banned.
The new facts from Public Citizen include the case of a 28-year-old woman who suffered fatal cardiac arrest while taking the drug. It also appears to affect unborn children, and has been linked to spontaneous abortions, stillbirths and congenital malformations, such as those of the heart and central nervous system.
Other, more common, side-effects include insomnia, constipation and a dry mouth.
The drug works by suppressing the appetite and increasing the speed at which the body feels full. It is reckoned to achieve an 8-per-cent weight loss after two years, a figure being disputed by Public Citizen.
With the risks outweighing the benefits, the drug should be banned in the USA, said the consumer group to the Food and Drug Administration (FDA), the US drugs regulator.