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this pageMeridia® Diet Drug Remains Available, Despite Safety Concerns
WASHINGTON, DC — September 2, 2005 — The Food and Drug Administration (FDA) will allow Meridia® (sibutramine) to remain on the market for now, despite the diet drug’s links to high blood pressure and deaths from heart attacks. The consumer advocacy group, Public Citizen, had unsuccessfully petitioned the agency to have Meridia® banned. The group says that the minor weight loss benefit provided by the drug does not offset its serious health risks.
“… The FDA has made another mistake,” Dr. Sidney Wolfe, the head of Public Citizen’s research group, said (Chicago Tribune, August 17, 2005). “A lot of the people who died from this [Meridia®] were very young, in their 20s, 30s and 40s. It is very difficult for the FDA to admit they made mistakes.”
Meridia®’s Health Risks Were Recognized
From the time of Meridia®’s approval in 1997 through August 2003, 224 users had nonfatal heart attacks, and 54 died, including 16 heart attack victims under the age of 50 (Wall Street Journal, August 18, 2005; Public Citizen Press Release, August 17, 2005). Meridia® prescribing instructions state that the medication can greatly increase blood pressure and pulse rate. The FDA now advises doctors to carefully monitor the blood pressure and pulse rate of their patients who take Meridia®.
Last fall, Dr. David Graham, associate director of the FDA’s Office of Drug Safety, testified before a Senate committee reviewing how the FDA handled drug approvals and withdrawals. He identified Meridia® and four other drugs as unsafe, and said that they should be recalled.
In 2002, the FDA sent a warning letter to Meridia®’s manufacturer, Abbott Laboratories, because it had failed to send the agency details about “adverse events” (Enforcement Activities 2002, scroll to Postmarketing Adverse Drug Experience Reports). Missing data included reports of serious, unexpected Meridia® side effects, follow–up information about adverse reactions, and details about the death of a Meridia® user. The FDA also noted date discrepancies between paper reports and the information from Abbott’s computer.
Questions arose about Meridia®’s safety even before it was approved. When the FDA’s Drug Advisory Committee met to consider Meridia® in 1996, five out of nine members determined that the medication’s benefits did not outweigh its risks (Endocrinologic and Metabolic Drugs Advisory Committee, Minutes, September 26, 1996). Of particular concern was Meridia®’s “limited and inconsistent ” benefits on lipid metabolism.
How Meridia® Works
The FDA approved Meridia® in November 1997 to treat obese patients, defined as those who need to lose at least 30 pounds. Patients taking Meridia® should follow a modified diet. Meridia® works by blocking the re–uptake of the brain chemicals serotonin and norepinephrine. This leads to a feeling of fullness and reduces the urge to continue eating, according to Abbott Laboratories. The drug brings in about $300 million a year for the company.
Your Meridia® Case
Brayton Purcell has been handling litigation involving medical/legal issues for over 20 years. We are presently evaluating cases involving Meridia® and other unsafe prescription drugs. If you or a loved one has suffered an injury from taking Meridia®, please feel free to contact us to learn about your legal options.