Public Citizen Petitions FDA to Ban Obesity Drug in Response to Reports of 19 Potentially Related Deaths

The consumer advocacy group Public Citizen filed a petition yesterday asking the FDA to remove Abbott Laboratories' prescription anti-obesity drug Meridia from the market in response to reports of 19 deaths that may have resulted from the treatment, the New York Times reports. The petition, which Public Citizen submitted to HHS Secretary Tommy Thompson, said that the FDA has received 357 reports of "serious adverse reactions" that may have resulted from Meridia -- including 152 hospitalizations and 29 deaths -- between February 1998, when the drug reached the market, and September 2001. Nineteen of the deaths resulted from heart disease, the petition said. Studies have found that Meridia can lead to a "sharp rise" in blood pressure and pulse rate in some patients. According to the petition, the FDA approved Meridia in 1997 against the recommendations of an agency advisory committee and an FDA medical officer who headed the review of the drug (Hilts, New York Times, 3/20). The medical officer had expressed concerns that the drug raised blood pressure "even when people were losing weight" (Carroll/Burton, Wall Street Journal, 3/20). The FDA required Abbott to include a warning on the Meridia label and a recommendation that doctors administer a blood pressure test to patients before prescribing the drug. The petition said that Meridia offers patients "minimal" benefits -- the loss of a few pounds over a "relatively short" period -- compared to "substantial" risks. Studies have found that patients who take the drug lose an average of six to 11 pounds in the first year of treatment (New York Times, 3/20). "This is a drug with no evidence of long-term benefit and significant evidence of short-term risk, including death," Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, said (Hellmich, USA Today, 3/20).

Laura Bradbard, an FDA spokesperson, said that the agency would review the petition and that the FDA has begun "looking into the adverse events of Meridia" (Wall Street Journal, 3/20). FDA spokesperson Susan Cruzan added, "FDA is currently viewing the adverse event data to determine if they were caused by the drug or by the underlying disease" (Ricks, Newsday, 3/20). Abbott said that the 19 deaths "had not been proved to be related" to Meridia (New York Times, 3/20). "We've been looking at these cases intensely, and we are confident there is no linkage" between the deaths and Meridia, Eugene Sun, divisional vice president for global pharmaceutical development at Abbott, said (Wall Street Journal, 3/20). Sun added, "Many of these patients unfortunately had serious complications of obesity, which is associated with increased mortality" (Japsen, Chicago Tribune, 3/20). According to obesity experts, "it's difficult to determine if people died because of the medication or because they were obese," a condition that placed them at increased risk for a number of diseases and death (USA Today, 3/20). Abbott said that the number of deaths that may have resulted from Meridia would represent a "very small" percentage of the nine million patients who have taken the drug (New York Times, 3/20). The company also said that the mortality rate of patients who have taken Meridia would account for "less that 1% of the mortality rate normally seen in obese people" (Chicago Tribune, 3/20). The petition is available online.