Public Citizen Calls on FDA to Ban Antidepressant
Prescribed More Than 4.5 Million Times Each Year,
Drug Can Cause Fatal Liver Damage, Lead to Dangerous Interactions
With Other Drugs
- March 6 - The consumer advocacy group Public Citizen today petitioned
the U.S. Food and Drug Administration (FDA) to remove from the
market the popular antidepressant nefazodone, manufactured by
Bristol-Myers Squibb. Nefazodone, marketed under the name Serzone,
has no unique therapeutic benefit and has led to at least 11 deaths
in the United States from liver toxicity, government records show.
2003, the manufacturer removed nefazodone from the European market
after the Swedish Medical Products Agency announced that it would
require a warning on the drug’s label about the potential for
liver toxicity. In the United States, more than 4.5 million prescriptions
were filled for Serzone in 2001.
"There is no
good reason to keep this drug on the market. It is no more effective
than other antidepressants, and it presents a unique health hazard
for patients," said Sidney Wolfe, M.D., director of Public Citizen’s
Health Research Group.
In its analysis
of adverse event reports from the FDA, Public Citizen found that
from 1994, when it was first marketed, to the spring of 2002,
nefazodone was associated with at lease 53 cases of liver injury,
including 21 cases of liver failure and 11 deaths. Worldwide,
Bristol-Myers Squibb itself acknowledges 28 reports of liver failure,
including 18 deaths.
while nefazodone is not more effective at treating depression
than older drugs, according to research by the federal Agency
for Health Care Policy and Research, it is uniquely dangerous
to patients. Further, periodic liver testing has not been shown
to prevent injury and there is no way to predict which patients
are at higher risk for liver damage.
by researchers in Spain found that, of 13 antidepressants, nefazodone
has the highest incidence of liver injury – seven to 22 times
that of the other antidepressants.
The liver toxicity
dangers of nefazodone are compounded by the fact that it inhibits
a key enzyme that is involved in the detoxification of about half
of all prescribed drugs, so nefazodone increases the toxicity
dangers of other drugs a patient is taking simultaneously. Also,
by inhibiting this enzyme, nefazodone can increase its own concentration
with potentially toxic results.
The FDA in
December 2001 notified Bristol-Myers Squibb that it must add a
"black box" warning to the package insert for nefazodone warning
of life-threatening liver damage and recommending that physicians
advise their patients to be aware of signs of liver problems.
But black box
warning does not go far enough to protect patients, particularly
because the labeling presented a confused message, the petition
said. Although the black box warning recommends monitoring of
patients’ liver function, a second notice on the label downplays
the necessity of such tests.
In the February
2002 issue of its monthly newsletter about drug safety, Worst
Pills, Best Pills News, Public Citizen labeled nefazodone as a
"Do Not Use" drug because of its known liver toxicity and recommended
that anyone who had been taking it consider switching to a safer
antidepressant. The petition and articles from the newsletter
about Serzone are posted online at www.worstpills.org,
a drug information service launched this winter by Public Citizen.
have known for a year to steer clear of this drug, and now patients
in Europe are protected, too," Wolfe said. "The FDA is endangering
the lives of patients in this country every day that it allows
nefazodone to remain on the market."
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