FDA Sued Over Antidepressant Serzone
Group Asks FDA to Ban Serzone Due to Risks of Liver Toxicity and Death
WebMD News Archive
March 15, 2004 -- A consumer advocacy group is taking the FDA
to court over an antidepressant drug that the group claims should be banned due
to the risk of death and serious injuries from liver failure.
The nonprofit group Public Citizen says it is suing the FDA
over the agency's failure to take action on Serzone to "protect public
safety and prevent needless death and injury."
In the lawsuit, filed yesterday in Washington, D.C., the group
claims that the FDA has "acted unlawfully" by not responding to the
group's petitions to withdraw the drug from the market.
Public Citizen first sought a ban on the drug in March 2003,
citing 21 cases of liver failure and 11 deaths between 1994 (when Serzone was
introduced) and the spring of 2002. A supplemental petition was filed in
October 2003, which included accounts of 33 additional reports of liver
failure, including nine deaths, filed with the FDA's adverse event reports
database from April 1, 2002, to May 12, 2003.
Serzone has already been taken off the market in Canada and
But the FDA has maintained that the risk of liver problems
associated with Serzone is rare. In 2002, the agency added its strongest
"black box" warning to the prescribing information for the drug, which
details these risks.
According to the warning, the rate of liver failure in the U.S.
is about one case of liver failure per 250,000-300,000 patient-years of
treatment with Serzone. A patient year is a summary of patient exposure to the
drug expressed in years. For example, one patient-year is equivalent to two
patients treated for six months, three patients treated for four months,
The drug's manufacturer, Bristol-Meyers Squibb, says it is not
directly involved in the lawsuit and cannot comment on it.
But company spokesman Robert Hutchinson says that since the
black box warning was issued, "There has been no new data that would alter
the risk-benefit of the product."
Where Does Serzone Fit In?
Serzone doesn't belong to the three most commonly used classes
of antidepressants (cyclic, MAOI, or SSRI) and accounts for only a small share
of antidepressants used in the U.S.