A consumer watchdog group called on the Food and Drug Administration on Wednesday to immediately remove the antidepressant Serzone from the market, citing 20 deaths from liver failure that have occurred since the drug was introduced nine years ago.
The advocacy group Public Citizen told the FDA that the drug has “no advantage” over other drugs used to treat depression and that it should no longer be prescribed.
“This is a doomed drug,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “There are ... other drugs for treating depression that are just as effective that don’t cause liver damage.”
The group first called for the ban in March, citing 11 deaths from liver failure that occurred after manufacturer Bristol-Myers Squibb Co. released Serzone into the market in 1994. The group said it learned of the deaths through the FDA’s “adverse event reports” database.
Since then, nine more people taking Serzone have died, Wolfe said.
Rob Hutchison, a spokesman for Bristol-Myers Squibb, said he could not confirm the 20 deaths, but that company data showed 12 deaths from liver failure in the United States in patients taking Serzone. Public Citizen said it did not know whether some of the deaths in the FDA database had occurred overseas.
Wolfe said he had also found reports of 55 cases of liver failure that did not result in death.
Bristol-Myers Squibb is withdrawing the drug in Canada and has discontinued sales in Europe amid concern by regulators over liver damage. Australia is the only other country where Serzone, known generically as nefazodone, is sold.
Three years ago, the FDA required a cautionary label to be added to the drug indicating it could cause liver failure. The agency also sent a warning letter to physicians, said Thomas Laughren, an FDA official.
The agency views cases of liver failure among Serzone users as a “rare event,” Laughren said, adding that not all patients being treated for depression respond to medication in the same way, and they benefit from having a range of treatment methods available.
“Patients and clinicians should have as many options as possible for treatment,” he said. “We think we’ve adequately characterized this risk in labeling. Individual clinicians and patients can assess that risk and make a decision.”
“We have not seen a change in our estimate of what the risk is. We have not changed our position on the availability of the drug,” Laughren said.
More than 11 million people have been prescribed Serzone since the drug was introduced, Hutchison said.
In its petition, sent Wednesday to FDA Commissioner Mark B. McClellan, Public Citizen said: “There is no justification for the U.S. to continue marketing a drug that offers no advantage in efficacy over the existing drugs in its class.... The mounting number of deaths from liver failure from a drug with no unique efficacy strongly argues for the removal of the drug from the market.”
Serzone is not considered identical to other antidepressant medications, such as Prozac, Paxil or Zoloft, Laughren said. Studies have shown that some patients experience less sexual dysfunction using Serzone than other antidepressants, he said. Laughren said the agency plans to review the group’s petition and will conduct an evaluation of the drug.
“Of course one doesn’t want deaths associated with the drug,” Laughren said. “If you ... have patients who do not respond to other drugs, you may in fact be saving lives by keeping drugs [they respond to] on the market.”