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this pageConsumer Group Again Urges Ban on Diet Drug
WASHINGTON, D.C. — September 9, 2003 —The diet drug Meridia (sibutramine, Abbott Laboratories/Knoll Pharmaceuticals) should be banned, according to a letter to the federal Food and Drug Administration (FDA) by the consumer group, Public Citizen. Meridia may increase levels of brain chemicals that help the patient feel full. However, it also increases blood pressure and heart rate, which leads to serious side effects, the group says.
Public Citizen had previously petitioned the FDA to halt sales of Meridia based on reports of 19 deaths from heart disease associated with the drug. Since that time, an additional 30 deaths have occurred because of Meridia use, according to the group. It also points to at least 126 new serious heart complications from Meridia, 63 of which required hospitalization. These problems included increased blood pressure, cardiac arrests, and heart failures.
Public Citizen also found that Meridia may effect pregnant women, causing spontaneous abortions, stillbirths, and birth defects. It lists this new information: four babies born with cardiovascular birth defects because of Meridia; 54 reports linking Meridia with fetal problems; and animal studies showing birth defects in progeny of rats and rabbits exposed to the drug.
“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 about Meridia. “...There is no justification in continuing to market a drug that provides minimal weight reduction while increasing the likelihood of injury and death.”
Years before, the FDA’s own Endocrinologic and Drugs Advisory Committee echoed some of the sentiments expressed by Public Citizen when it originally voted 5 to 4 against the drug’s approval (Endocrinologic and Metabolic Drugs Advisory Committee #64, FDA, 1996). One of the agency’s medical officers, Dr. Eric Colman, had great concern about sibutramine’s effects on blood pressure. Others mentioned that the drug’s risks did not outweigh its benefits.
At Brayton Purcell, we are concerned about unsafe medical drugs and have experience in handling cases about pharmaceutical injuries. If you have a question or concern about your medical drug exposure, please feel free to contact us for your legal needs.