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Diet Drug Ban Urged
Deaths, birth defects cited
THE ASSOCIATED PRESS; This story was supplemented with information from The Washington Post.
September 5, 2003
Washington - A consumer group is again urging a ban of the prescription diet drug Meridia, saying at least 49 users have died of heart problems, including some in their 20s and 30s.
The Food and Drug Administration also has 54 reports of women who suffered stillbirths, miscarriages or had babies with birth defects while using Meridia, Public Citizen said Wednesday. Among them were four babies born with malformed hearts, similar to defects seen in some animal experiments with the drug.
Women are not supposed to diet during pregnancy, and the drug's label does not mention fetal harm if a woman becomes pregnant while taking Meridia. But Meridia does bear a warning that it can substantially raise some people's blood pressure, so users should be monitored and those with certain health problems should not take it.
Public Citizen's Sidney Wolfe said that warning is not enough. He said the FDA has received reports of 30 more Meridia users who died of heart attacks or cardiac arrest since he first petitioned the agency for a ban in March of last year.
"The number of victims is rising rapidly," Wolfe wrote FDA Commissioner Mark McClellan. "There is no justification in continuing to market a drug that provides minimal weight reduction while increasing the likelihood of injury and death."
FDA officials would not comment on Meridia's safety, saying only that they were evaluating Wolfe's petition.
Meridia manufacturer Abbott Laboratories called Wolfe's allegations irresponsible, saying recent re-examinations by European and Canadian regulators concluded the drug is safe.
Obesity itself puts people at serious risk of premature death from heart problems, Abbott noted.
Doctors voluntarily report possible side effects to the FDA, which monitors those reports for signs of drug risks. Filing a report does not prove a drug was to blame; conversely, the FDA says only a small fraction of side effects get reported.
An estimated 10 million people worldwide have used Meridia, which the FDA has called a "moderately effective" weight-loss aid for the obese. Just under 1 million Meridia prescriptions are written annually in the United States, an Abbott spokeswoman said.
Wolfe said in addition to the 49 deaths, 124 users have been hospitalized for serious heart and cardiovascular problems since the drug was approved.
This story was supplemented with information from The Washington Post.
Copyright © 2003, Newsday, Inc.
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Copy of original article in New York's Newsday newspaper dated 3/19/02:
Groups Asks Ban on Obesity Drug Linked to Deaths
By Delthia Ricks
Staff Writer
March 19, 2002, 6:10 PM EST
A watchdog group yesterday petitioned the Food and Drug Administration to ban the anti-obesity medication Meridia, linking the drug to 29 deaths in the United States and four in Europe.
Calling the medication "unacceptably dangerous,” Public Citizen, based in Washington, D.C., asked the FDA to reconsider its 1997 approval of Meridia, saying people who take it risk serious cardiovascular complications. The consumer group listed heart attack, stroke and heart rhythm abnormalities as the primary complications. Of the 29 deaths in the United States, the consumer group said 19 could be directly linked to cardiovascular causes.
"Not only does this drug contribute to major cardiovascular problems, but its effectiveness in lowering obesity is meager,” said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.
The consumer group also found 397 "serious adverse reactions” to the medication. All of the complications, the group said, occurred since 1998. Public Citizen's researchers discovered the complications in documents submitted to the FDA by the drug's maker, Abbott Laboratories of Abbott Park, Ill., as well as in information submitted to the agency by doctors. The watchdog organization used the federal Freedom of Information Act to secure the documents.
Susan Cruzan, FDA spokeswoman, said the regulatory agency is examining the petition as well as deaths and illnesses linked to the drug abroad. "As with any drug, we don't say that it is safe and effective for every person,” Cruzan said. "FDA is currently reviewing the adverse event data” she said of the deaths, "to determine if they were caused by the drug or by underlying disease.”
Meridia, which costs about $126 for a 30-day supply, is taken as a daily pill. It functions by exerting activity on key chemical pathways in the brain. The result is the patient's feeling satiated, doctors say. The group's petition cited only a six-pound weight loss, on average, saying Meridia's risks far outweigh its benefits. The group's action comes on the heels of the Italian government's suspension of the drug following reports two weeks ago of two deaths linked to the medication.
Meridia is sold as Reductil in Europe, and is marketed in 70 countries worldwide, Abbott spokeswoman Jennifer Smoter said. She estimated approximately 8.5 million people globally have taken Meridia since its approval. An estimated 2 million people in the United States currently take the medication, Smoter said. The drug, listed as one of the nation's most widely advertised prescription drugs, earns Abbott in excess of $100 million annually.
"We have analyzed the deaths that have been reported to Abbott and they do not point to use of ,” Smoter said.
Yet deaths linked to it continue to surface, Public Citizen charged yesterday. Two have been reported in Britain, the group said. British health authorities have not suspended or banned use of the drug. French officials have linked the drug to 99 complications, according to Public Citizen.
Dr. Judith Korner, an assistant professor of medicine at Columbia University's College of Physicians and Surgeons, said she would be dismayed if the drug were banned.
"I've not had any problem with it at all. But I select my patient population very carefully,” Korner said. "I don't know of any information suggesting that the drug should be banned. That would be unfortunate.”
Korner and other obesity specialists cited a paucity of medications to treat severe obesity. Public Citizen's petition is its fifth filed in six years. The last four were for the diet drug Redux, which was banned in 1997; the diabetes drug Rezulin, banned in 2000; the irritable bowel drug Lotronex, banned in 2000; and the antibiotic, Trovan, whose use was severely restricted by the FDA, also that year.
Copyright © 2003, Newsday, Inc.
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