A consumer advocacy group is petitioning the government to ban the weight loss pill Meridia because a recent study suggests it increases risk of heart attack, stroke and death.
A letter Thursday from Public Citizen calls on the Food and Drug Administration to pull Abbott Laboratories' drug from the U.S. market, where it is used by roughly a quarter million people.
Preliminary results from a 10,000-patient study _ known as the SCOUT study _ showed a slightly higher risk of heart-related problems in patients taking Meridia, also called sibutramine, compared with a dummy pill. Patients in the study were older than 55, overweight with a history of heart disease or diabetes.
FDA said it was "making no conclusions about the preliminary findings," when they were released last month.
But Public Citizen's Dr. Sidney Wolfe said the agency must take action.
"We would hope that the science behind the results seen in this study would mandate the only appropriate FDA action to protect the public health: immediate removal of 'Meridia' from the market," states the letter from Wolfe, who directs the group's Health Research Group.
North Chicago-based Abbott said it has not reviewed Public Citizen's petition, but said Meridia is only approved for patients who have no previous history of cardiovascular disease.
"Sibutramine is not recommended or approved for use in more than 90 percent of the patients who participated in the SCOUT study," said spokesman Kurt Ebenhoch. "Abbott's assessment is that the data do not indicate a change in the safety profile of sibutramine when used in the approved patient population."
Ebenhoch said European regulators asked Abbott to perform the study.
FDA previously rejected a 2002 petition from Public Citizen to withdrawal Meridia. In its rejection notice the FDA suggested it wanted to wait for the findings of the 10,000-patient study.
Public Citizen said there had been a total of 84 deaths associated with Meridia reported to FDA as of June this year.
FDA approved Meridia in 1997 as a weight loss aid alongside diet and exercise. The drug is related to the amphetamine family of stimulants.
Public Citizen pointed out that the agency's panel of outside specialists voted 5 to 4 that the drug's risks outweighed its benefits. The agency isn't required to follow their advice, though it often does.
Abbott shares slipped 20 cents to close at $54.24 Thursday.