March 22, 2002 -- A watchdog group is calling for the FDA to ba
March 22, 2002 -- A watchdog group is calling for the FDA to ban the diet drug Meridia, noting that the drug has been associated with 29 deaths and hundreds of serious side effects.
The group Public Citizen is petitioning the FDA to withdraw its approval of Meridia. It claims that the drug offers only a small benefit -- at the cost of a serious risk to health.
Meridia manufacturer Abbott Laboratories admits that at least 32 patients have died while taking the drug. But it points out that some 9 million people have used the drug in the last five years.
Eugene Sun, MD, is Abbott's vice president of global drug development.
"Thirty-two out of 9 million is a very small number," Sun tells WebMD. "If you multiply that by 10 to correct for likely underreporting, that is still substantially below the expected [death rate] for an obese population. When we look at these cases, we can't find a link to the drug in any of them."
Sidney M. Wolfe, MD, director of the Public Citizen Health Research Group, says that FDA documents link Meridia to nearly 400 serious bad reactions from February 1998 through September 2001.
"It is reckless and irresponsible to say that the drug risk is no lower than would be expected," Wolfe tells WebMD.
Clinical studies show that Meridia can help people lose a little weight -- about six and a half pounds at the standard dose -- after a year's use. During a second year of use, most people regain some of this weight, but not as much as people who don't take the drug. When people stop taking Meridia, they tend to gain back the weight they lost.
These studies also show that the drug increases blood pressure. It's a small increase, but any increase in blood pressure can be bad news for an obese person. And a few patients have a very serious increase in blood pressure. The drug also increases a person's heart rate.
"There is no evidence that this drug has prolonged the life of a single patient, or reduced the risks of strokes or heart attacks tied to obesity," Wolfe says. "Instead, it has left patients with only higher risks of injury or death from using it -- and high drug bills."
An Abbott news release says that the weight loss Meridia offers would be expected to decrease the risk of heart disease and death in obese patients. Sun says that no patient died in any clinical trial of Meridia and that the drug's safety record is excellent when used as directed.
Wolfe notes that an FDA advisory committee voted 5-4 against approving Meridia. A year later, the FDA overruled this committee and approved the drug. Wolfe says the FDA ignored important safety findings; Sun says that the agency had better information at the time it approved the drug, and that this approval was both scientific and appropriate.
The Medical Letter, a nonprofit organization, has its own panel of independent experts evaluate drugs for doctors. In its issue of March 13, 1998, these consultants said doctors should not prescribe the drug.
Italy's drug-regulating agency already has banned Meridia, but other European nations have not followed suit. Sun says Italy is reconsidering its position.
So what will happen? Public Citizen has a strong track record. It's petitioned the FDA to ban four other drugs. Three were banned -- including the diet drug Redux -- and one was severely restricted.
"This drug is going to be taken off the market," Wolfe predicts.
"We are very confident it won't be taken from market," Sun says.
Time -- and the FDA -- will tell.-->
