A consumer group Wednesday reiterated its request that the government immediately ban sales of Meridia, a prescription diet drug.
Public Citizen said in a letter to Food and Drug Administration Commissioner Mark McClellan that it reviewed the FDA’s database and found 49 cases of deaths from cardiovascular causes among Meridia users. The review covered the period from February 1998, when the drug was launched, through March 2003.
Most deaths occurred in people younger than 50, including two women aged 28 and 30, according to Public Citizen. The Washington-based group also found 124 reports to the FDA of cardiovascular problems that required hospitalization.
In a statement Wednesday, Meridia maker Abbott Laboratories said that obesity itself increases the risk of premature death and cardiovascular problems.
“There were more than a hundred clinical trials” of Meridia, says Abbott spokeswoman Catherine Bryan. “This is one of the most tested products in the obesity category.” An estimated 10 million people in 70 countries have taken Meridia, Bryan says.
Obesity experts have said it would be hard to tell whether the drug â€” approved for people 30 pounds overweight or more â€” or obesity contributed to the deaths of Meridia users.
But Sidney Wolfe, director of Public Citizen’s Health Research Group, notes that in the studies leading to Meridia’s approval, patients on the drug were more likely to have a sustained increase in blood pressure than patients on a placebo. Since high blood pressure itself is a risk factor for heart disease, “that sort of trumps that whole issue that it’s just because they’re fat,” Wolfe says.
Public Citizen also found 54 reports in the FDA database of “maternal drugs affecting fetus” or “complications of maternal exposure” where Meridia was listed as the main suspect drug, even though its label says use during pregnancy is not recommended.
Before Meridia was approved, an FDA staff member reported that animal studies had found cardiac abnormalities in pups born to rats and rabbits given the drug, according to Public Citizen. No such problems were seen in the offspring of animals that did not get Meridia, the group says.
FDA spokeswoman Laura Bradbard says the agency is working on a response to Public Citizen’s petitions. “The agency is looking at all of the data,” Bradbard says.