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Bayer
Voluntarily Withdraws Baycol
FDA Talk Paper - August 8, 2001
WASHINGTON (Reuters) - Bayer AG's cholesterol-fighting
drug Baycol, which the German drug giant
pulled from the market Wednesday, was linked
to 31 U.S. deaths from a muscle-related
side effect, health officials said.
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FDA
says Withdrawn Bayer Drug Linked to 31 Deaths
Reuters News Service - August 8, 2001
FDA today announced that Bayer Pharmaceutical
Division is voluntarily withdrawing Baycol
(cerivastatin) from the U.S. market because
of reports of sometimes fatal rhabdomyolysis,
a severe muscle adverse reaction from this
cholesterol-lowering (lipid-lowering) product.
The FDA agrees with and supports this decision.
~~~~~~~~~~~~~~~~~
Drug's
Problems Raise Questions on Warnings
New York Times - August 21, 2001, By
Philip J. Hilts
When Baycol, a cholesterol-lowering
drug, was approved in 1997, it appeared
to be a potentially lifesaving drug with
few side effects. It had been tested on
more than 3,000 patients, and no serious
problems had turned up. ...
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If you took Baycol
and experienced any adverse reactions you
may have a valid legal claim.
Baycol,
a 'statin' drug sold for lowering cholesterol,
was approved by the FDA in 1997. Prior
to its release, it had been tested on more
than 3,000 patients. Statins are powerful
anti-cholesterol drugs that save lives by
prevention of heart attacks and strokes.
Six statins are left on the market in the
United States, and about 12 million people
take them.
Sales
of Baycol (generic name cerivastatin) were
projected to reach $800 million in 2001,
but the German manufacturing company, Bayer
A.G., took Baycol off the market after 31
patients on the drug had died suspiciously
of rhabdomyolysis.
Rhabdomyolysis
is classed as a disorder rather than a disease.
In rhabdomyolysis, muscle cells break down,
flooding the kidneys with cellular
waste. Death occurs when the kidneys are
overwhelmed and shut down.
As
early as December 1999, with the original
reports of muscle problems and deaths linked
to Baycol, both Bayer and the Food and Drug
Administration warned doctors to take precautions
when prescribing it. As the problem
continued, Baycol had to be taken off the
market.
Doctors
were sent advisories to:
- not
start patients on the highest dose
- not
to give patients both cerivastatin and
Lopid, or gemfibrozil, a nonstatin drug
that lowers blood triglyceride levels
and cholesterol. These drug combinations
seem to increase risk.
Many doctors
deny receiving such advisories.
In
the United States, Public Citizen's Health
Research Group, a medical watchdog organization
in Washington, said it had found 81 reports
of deaths from rhabdomyolysis linked to
statin drugs other than cerivastatin since
the late 1980's.
Government
statisticians have calculated that there
were probably about 10 cases of side effects
for each case reported to the F.D.A.
Product liability
laws and medical malpractice or negligence
laws are guided by personal injury law. The
primary aim of personal injury law is to
provide relief through compensation to
injured parties for the damages incurred.
Among the types of recoverable damages are:
loss of earning capacity, pain and
suffering, and reasonable medical expenses.
Damages include both present and future
expected losses.
- Product
Liability: Defective products
such as prescription drugs which are not
properly labeled as to interactions or
other contraindications. Your attorney
can evaluate your legal rights and advise
you of possible compensation.
- Professional
Malpractice: Medical malpractice
or negligence may involve delay in treatment
or incorrect treatment or missed diagnosis.
Your lawyer can protect your rights and
represent your interests.
- Wrongful
death: Fatal injuries
due to negligence or other liability may
bring compensation to heirs or estate.
Seek legal counsel before the statute
of limitations becomes an issue.
If you have rhabdomyolysis and kidney failure
after or during use of a statin drug,
the maker of Baycol, Bayer Corporation,
or another manufacturer of another statin
drug may be liable for compensation. Your
lawyer can counsel you as to your
right to recover damages to help defray
the costs of treatment and provide compensation
for your pain and suffering.
Drug litigation can be complex. It
is best to seek the counsel of a personal
injury attorney with experience in this
field of law.
If you feel that you are having a reaction
to a statin drug, stop the drug immediately
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