 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 ubject 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be the next FDA approved drugs to be withdrawn from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been withdrawn from the market as a result of life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withdrawn after reports of at least 31 deaths linked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and was withdrawn from the market in August 2001.
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 Before being withdrawn after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and Redux were voluntarily withdrawn by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obesity were withdrawn after being linked to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 By the time these drugs were withdrawn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.
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.
Raplon: This muscular block injection was used to help intubation
prior to surgery, however, it had to be withdrawn
from the market after it caused a number of fatalities
and serious cardio pulmonary reactions. Prior to its
withdrawal Raplon was given to about a million patients.
Lotronex: This medication, used to treat irritable bowel syndrome
in women, was withdrawn after reports of serious adverse
effects, including multiple deaths, but it is now
back on the market. An investigative article published
by the Los Angeles Times in November, 2000 found that
multiple patients developed potentially life threatening
complications as a result of ingesting Lotronex. The
FDA chose a paid consultant from Glaxo Wellcome, Lotronex’s
manufacturer, to serve with an advisory committee
that recommended approval of the drug. Further, the
FDA permitted GlaxoWellcome to put Lotronex on the
market without conducting a major new study of its
link to ischemic colitis, a potentially fatal condition.
Posicor: This heart failure treatment was placed on the market
despite increased numbers of sudden cardiac deaths
in people using the drug. It was not withdrawn from
the market until after 600,000 people had been prescribed
it. Swedish authorities had taken Posicor off the
market in 1997. The FDA, however, approved use of
the drug, despite over 140 deaths in patients in an
ongoing study. Posicor was withdrawn from the market
less than one year after being FDA approved. By the
time it was withdrawn reports indicated it was linked
to 100 deaths, and patients who had been prescribed
Posicor died at a rate of about 10% greater than those
who were prescribed its competitor.
Hismanal: This antihistamine manufactured by Janssen Pharmaceuticals,
was withdrawn from the market after severe cardiovascular
events and potentially life threatening reactions
to the drug were reported.
Hismanal
has been associated with the risk of death due to
irregular heart rhythms when taken in combination
with other drugs.
Seldane: This commonly used prescription antihistamine, was
withdrawn from the market in 1997. Even though Seldane
was linked to a large number of cases of fatal or
near fatal heart arrhythmias, the FDA waited to withdraw
this drug until its manufacturer, Hoechst Marion Rouffel,
received approval for the marketing of Allegra, a
different antihistamine.
Raxar: An antibiotic used in the treatment of an estimated
2.65 million patients, was withdrawn as a result of
severe cardiovascular events and deaths amongst patients.
By the time of its withdrawal, this drug had generated
$23 million in sales for its manufacturer Glaxo Wellcome,
Inc., now known as Glaxo Smith Kline, according to
an L.A. Times Article.
Given the
frightening number of drugs withdrawn for safety issues,
one must question the power which drug companies wield
with the FDA and whether they are rushing new products
to the market.
With high
pressure marketing campaigns, drug companies can rack
up millions in sales on drugs even if they are only
on the market for a short time. However, the cost
to the patients who are prescribed dangerous medications
is simply too high to bear.
If you,
or a family member, has been injured by a dangerous
drug you can call Bonina & Bonina, P.C. for a
free consultation at 1-888-MEDLAW1. |
