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this pageBan on Diet Drug Meridia
WASHINGTON, D.C. — March 29, 2002 — The consumer’s group, Public Citizen, has asked the federal Food and Drug Administration (FDA) to prohibit the sale of the prescription diet drug sibutramine (Petition to FDA, Health Research Group). Marketed in the United States as Meridia by Abbott Laboratories/Knoll Pharmaceuticals, sibutramine is purported to increase levels of brain chemicals that help reduce appetite. It may increase blood pressure and heart rate, however, leading to serious side effects.
Since 1998, Meridia has been associated with 397 severe adverse reactions and 29 deaths nationwide, including 19 from cardiovascular complications, according to FDA data cited by Public Citizen. The group has called sibutramine “unacceptably dangerous.”
When asked if the benefits of sibutramine outweighed its risks, the FDA’s own Endocrinologic and Drugs Advisory Committee 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, expressed great concern about sibutramine’s effects on blood pressure.
Sibutramine Problems Occurring Worldwide
Problems with sibutramine are not limited to the United States. The Italian Health Ministry has suspended sales of the drug after reports of two related deaths. Italian officials said they received 50 complaints about side–effects from sibutramine, which is sold under the name Reductil in Italy and in many other European countries (Chicago Tribune, March 9, 2002).
In France, officials reported 99 cases of side effects from sibutramine, 10 of them serious (Chicago Tribune, March 16, 2002). In Britain, two patients who took sibutramine died, and 212 had adverse reactions (The Scotsman, March 16, 2002). In response to the worldwide reports, the State Drug Administration in China is conducting an investigation of all weight–loss drugs, including sibutramine (ChinaOnline, March 25, 2002; search on sibutramine, article may be accessed for a fee).
In the United States, the FDA has said that it is monitoring all overseas sibutramine reports, but it has yet to take action against Meridia. Public Citizen’s request for a Meridia ban has been listed on the agency’s March docket for consideration. Abbott Laboratories continues to defend the drug’s safety.
Brayton Purcell is experienced in handling cases about pharmaceutical injuries. If you have a question or concern about your drug exposure, please feel free to contact us for your legal needs.