Weight-Loss Drug Safety Questioned

March 19 -- A national consumer organization wants the Food and Drug Administration to remove the weight-loss drug Meridia from the market because of deaths and health problems it says are associated with the drug.

Meridia has been associated with 29 deaths and 397 serious adverse events such as arrhythmia and high blood pressure in the United States since its approval in 1998, according to the Public Citizen petition to the FDA. The drug is also known as sibutramine.

"The drug should have never been put on the market — the advisory committee and the physician in charge of the drug both recommended against approval," said Dr. Sidney Wolfe, director of Public Citizen in Washington. "This is a mistake that is being corrected. The drug is just not going to survive much longer."

But Abbott Laboratories, which markets the drug under the name Reductil in Italy and Meridia in the United States, stands by the safety of sibutramine. While company officials acknowledged there have been fatalities allegedly related to sibutramine use, they said that obese people have greater health problems generally.

The Public Citizen petition in the United States follows concerns elsewhere over the drug's safety. Early this month, the Italian Health Ministry announced that it was temporarily suspending marketing of all sibutramine-containing products in the wake of two deaths and 50 additional reports of health problems linked to sibutramine use.

Sibutramine was the first weight-loss drug to be given the OK since the 1997 bans on Redux, also known as dexfenfluramine, and fenfluramine, the "fen" in fen-phen, following reports that the drugs caused heart valve damage.

Abbott Stands by Its Product

According to Abbott Laboratories, an estimated 9 million people have taken sibutramine for weight management worldwide since the drug was first approved.

Dr. Eugene Sun, Abbott vice president of pharmaceutical development, said the company is aware of 32 cases of fatalities worldwide with a possible sibutramine link. "We have done a careful analysis of all 32 cases, and in none of those cases do we see a clear link between the use of sibutramine and the deaths," Sun said.