Sept. 3, 2003
Public Citizen Criticizes FDA for Failing to Ban Dangerous Diet Drug
Growing Number of Cardiac Deaths and Fetal Toxicity Linked to Meridia
WASHINGTON, D.C. – Public Citizen today renewed its call to the U.S. Food and Drug Administration (FDA) to immediately remove the prescription diet medication Meridia from the market based on new evidence of a rapidly growing number of deaths and serious adverse reactions.
“The reactions are serious, the number of victims is rising rapidly and the effectiveness in treating obesity is meager,” Sidney Wolfe, MD., director of Public Citizen’s Health Research Group, said in a second petition to the FDA. “The FDA is in possession of evidence sufficiently clear to immediately ban this serious health hazard, known to cause dangerous increases in blood pressure.”
In its original March 2002 petition, Public Citizen, a national consumer advocacy organization cited 19 deaths from cardiovascular disease and 61 serious cardiovascular adverse reactions resulting in hospitalization in patients taking Meridia. Since the FDA’s failure to address the petition, a subsequent review of the FDA database (covering the past 18 months) reveals an additional 30 heart-related deaths in people using Meridia – for a total of 49 cardiovascular deaths, the majority of which were in people less than 50 years old, two in women aged 28 and 30. In addition to the cardiovascular deaths, there are now a total of 124 cardiovascular adverse reactions serious enough to require hospitalization.
A troubling new category, which was not addressed in Public Citizen’s original petition, is the impact of Meridia on the developing fetus. When pregnant women take the drug, the new analysis indicates a link to spontaneous abortions, stillbirths and congenital malformations, including those of the heart and central nervous system in the fetus. The cardiovascular birth defects seen in four babies are consistent with those seen in animal studies, prior to approval of the drug.
“There is no justification in continuing to market a drug that provides minimal weight reduction while increasing the likelihood of injury and death,” Wolfe said.
Even before it approved the drug, the FDA was concerned about the safety of Meridia. An FDA advisory committee in 1997 voted 5-4 that the benefits of the drug did not outweigh its risks.
To read the entire petition, click here.