Consumer advocacy group Public Citizen on Tuesday asked US regulators to ban Abbott Laboratories' diet drug Meridia, linking the anti-obesity medicine to several deaths in the United States and Europe.
The consumer watchdog's petition to the US Food and Drug Administration comes as Abbott's anti-obesity prescription drug is under fire by health officials in Europe who linked the medicine to deaths and adverse side-effects.
Public Citizen called the drug "unacceptably dangerous' in its petition, and cited an FDA database associating the drug, known by the chemical name sibutramine, with 29 deaths since its US launch in early 1998. Public Citizen said 19 of those deaths were caused by cardiovascular adverse effects in people who used the drug.
Abbott, based in northern Chicago, said last week it was aware of the deaths, but denied there was evidence the deaths were linked to taking the drug, which is marketed in the United Kingdom as Reductil.
Nearly 9 million people have used sibutramine-based drugs since 1997, and Abbott has stressed that the death rate was less than 1 per cent of the mortality normally seen in obese people who often suffer from other conditions such as heart disease and diabetes.
Meridia had US sales of $84 million (€96m) in 2001, a fraction of Abbott's total sales last year of $16.2 billion.
Public Citizen said this is the fifth petition it has filed with the FDA to ban a drug since 1996. Previous petitions include a prohibition of the diet drug Redux, which was later banned in September 1997, and the diabetes drug Rezulin, which was banned in March 2000.
Prior to its approval in 1997, some FDA advisors voted against approving the drug, which Abbott inherited when it acquired Knoll Pharmaceuticals last year, because sibutramine slightly elevated blood pressure in studies.
According to a Public Citizen statement, the FDA medical officer who reviewed the drug wrote that "sibutramine has an unsatisfactory risk-benefit ratio and therefore this reviewer recommends non-approval of the original submission".
"The concern of both the advisory committee and the FDA medical officer was based on the fact that sibutramine significantly increases blood pressure and heart rate in many people," the watchdog agency said.
Earlier this month, health officials in Italy withdrew all sibutramine products from the market due to 50 reports of health-related problems - the first such move by any country since the drug was approved. British health authorities have associated two deaths and 212 reports of suspected adverse reactions in patients who have taken Reductil.
Last week, French drug regulators reported that they had received 99 reports of side effects, 10 of them serious, but no fatalities in patients taking sibutramine.