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Public Citizen calls on FDA to pull weight loss drug citing serious health issues
2009-12-07 19:59:39 (GMT) (Caymanmama.com - Health News News)
Atlanta, Georgia (CaymanMama.com) — A consumer rights group is working a petition to the U.S. government asking that the Food and Drug Administration ban the weight loss drug Meridia following a recent study that suggests the pill increases risk of heart attack, stroke and death.
Public Citizen sent a letter to the FDA on Thursday asking they the agency pull Abbott Laboratories’ drug from the American marketplace, where it is used by approximately a quarter million people.
Preliminary findings from a 10,000-patient study indicated a marginally higher risk of heart-related problems in patients using the Meridia pill, also called sibutramine, compared with a placebo. The study’s subjects 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 the results were published last month. Public Citizen doctor Sidney Wolfe, who directs the group’s Health Research Group, said the FDA needs to take action — and quickly.
“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,” Wolfe said in a letter.
Abbott Laboratories said it has not looked over the petition, but said their weight loss drug is only approved for people 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.”
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