THURSDAY, OCTOBER
30, 2003
By Shweta Govindarajan
Washington – 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 charged 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.”
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