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In
December 2001 the Food and Drug Administration ordered
Bristol Meyers Squibb Co., to include a “Black
Box Warning” on the label of their popular antidepressant
drug Serzone informing patients that life threatening
liver damage could occur with the use of that drug.
Physicians
have been advised that patients taking Serzone should
be told to report signs and symptoms of liver dysfunction
such as jaundice, anorexia, or gastrointestinal complaints
to their doctors immediately. Doctors have also been
warned that any heightened liver function study tests
should result in the patient being removed immediately
from Serzone.
Abbott Laboratories’
diet drug Meridia has also been the subject of scrutiny.
After reports of heart attacks, strokes and deaths
associated with Meridia, the Italian government pulled
it from the market in March. A later FDA inspection
reportedly revealed that Abbott had withheld information
regarding deaths associated with the drug from the
FDA. Now consumer advocacy groups are urging a ban
on Meridia and criminal charges against its manufacturer.
All of this
activity begs the question: Will Serzone and Meridia
be the next FDA approved drugs to be withdrawn from
the market?
Since 1997
an incredible 12 different FDA approved drugs have
been withdrawn from the market as a result of life
threatening risks to patients taking those drugs.
These drugs include:
Baycol:
Baycol, manufactured by Bayer Pharmaceuticals, was
withdrawn after reports of at least 31 deaths linked
to the drug. Baycol, a drug marketed to lower cholesterol
was initially approved to the U.S. market in 1997
and was withdrawn from the market in August 2001.
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Consumer Corner
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All of the deaths were linked to rhabdomyolysis,
a disorder that destroys muscle tissue. Most
of those who died developed kidney failure following
use of the drug. Before being withdrawn after
only 4 years on the market, Baycol resulted
in $615 million in sales for Bayer Pharmaceuticals.
Pondimin
and Redux were voluntarily withdrawn by
Wyeth-Ayerst Laboratories in September of 1997.
These prescription drugs for the treatment of
obesity were withdrawn after being linked to
hundreds of cases of heart disease and heart
valve damage. By the time these drugs were withdrawn
from the market six million Americans had taken
them. Reports indicate an estimated 30% of those
individuals had abnormal echocardiograms.
Propulsid:
Propulsid, a heartburn medication, was taken
off the market in March of 2000 after significant
reports of hundreds of deaths and heart rhythm
abnormalities.
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Propulsid
was widely prescribed to both adults and children.
During the time it was on the market its label
had to be revised on multiple occasions because
of the severity of risks it posed to patients.
Duract:
Duract, a pain reliever medication, was withdrawn
from the market as a result of liver toxicity.
The fact that this medication could cause liver
toxicity was known prior to its approval by
the FDA. Nonetheless it was approved for short
term use, despite being only marginally better
for pain relief than Tylenol. By the time that
this drug was banned it had been associated
with multiple deaths and liver transplants.
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