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Antidepressant Serzone (nefazodone)
FDA
Should Follow Lead of Europe, Canada to Remove Serzone from Market, Public
Citizen Says
WASHINGTON,
D.C., Oct. 30, 2003 - New reports of deaths and severe injuries from
liver failure in patients taking the
antidepressant Serzone (nefazodone)
require that the U.S. Food and Drug Administration
(FDA) act immediately
to protect U.S. patients, Public Citizen said today.
Public Citizen
submitted a supplement containing new data to its March
2003 petition
requesting the withdrawal of this uniquely dangerous
drug from the
market.
Just this month,
Canada announced it would remove from the market the
liver-toxic drug due to its association with "hepatic
adverse events
such as jaundice, hepatitis and hepatocellular
necrosis." A "Dear Health
Care Professional" letter posted on the Health Canada
Web site makes an
irrefutable case for removing the drug, Public Citizen
said in its
supplement.
Bristol-Myers
Squibb manufactures nefazodone and markets it under the
name Serzone. More than 2.8 million prescriptions were
filled for
Serzone in the United States in 2002.
In its original
petition, Public Citizen cited 21 cases of liver
failure and 11 deaths from 1994, when nefazodone was
first marketed, to
the spring of 2002. A new analysis of the FDA Adverse
Event Reports
Database found that, just from April 1, 2002, through
May 12, 2003,
there were 33 additional reports of liver failure -
including nine
deaths - for a total of 55 patients with liver failure,
including 20
deaths.
"Typically, it
is estimated that only about 10 percent of cases are
reported, meaning that potentially hundreds of people
have died from
this drug and hundreds more have been injured," said
Dr. Sidney Wolfe,
director of Public Citizen's Health Research Group.
"This drug is no
more effective than other antidepressants, but is
uniquely and
unpredictably toxic."
The liver
toxicity dangers of nefazodone are compounded by the fact
that it inhibits a key enzyme that is involved in the
metabolism of
about half of all prescribed drugs, so nefazodone
increases the toxicity
dangers of other drugs a patient may be taking. 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.
This strategy has
clearly failed to curb the cases of liver failure and
death caused by
the drug.
However, the
"Dear Health Care Professional" letter posted on the
Health Canada Web site makes it clear that it is not
possible to manage
this drug safely, saying, "To date, no risk factor to
predict patients
who will develop irreversible liver failure with
nefazodone [Serzone]
has been identified. Also, no clinical strategy, such
as routine liver
function tests, could be identified to reduce the risk
of liver
failure."
"Once again, the
United States is lagging behind other countries in
drug safety. Any delay by the FDA in removing this drug
from the market
will cause more patients to be injured or killed,"
Wolfe said.
A copy of Public
Citizen's supplementary petition is available on the
Web at
http://www.citizen.org/publications/release.cfm?ID=7288. The
original petition is posted at
http://www.citizen.org/publications/release.cfm?ID=7233.
Public Citizen
is a nonprofit consumer advocacy organization based in
Washington, D.C. For more information, please visit
www.citizen.org. |
