Consumer advocacy group Public Citizen on Wednesday renewed its call for U.S. regulators to ban Abbott Laboratories Inc.'s diet drug Meridia, saying it has been linked with more deaths.
Since its March 2002 petition for a ban that cited 19 heart-related deaths since Meridia's 1998 U.S. launch, Public Citizen said it has looked at another 18 months of data and found an additional 30 cardiovascular deaths in people using the drug.
"The reactions are serious, the number of victims is rising rapidly and the effectiveness in treating obesity is meager," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, in a statement announcing the second petition to the Food and Drug Administration.
The group also said it was seeing in the FDA's own database a link with spontaneous abortions, stillbirths and congenital defects when pregnant women take the drug. Public Citizen said it based the call for a ban on its analysis of data from the FDA Adverse Event Reporting System.
Of the 30 newest cardiovascular deaths among Meridia users, 25 reports provided ages and 17 of those people, or 68 percent, were younger than 50. Since the 1998 U.S. launch of Meridia through March 2003, there were also 124 serious cardiovascular events requiring hospitalization, the advocacy group said.
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