Baycol Recall
On
August 8, 2001, Bayer AG withdrew the drug Baycol from
the U.S. market after it caused the deaths of 31 patients
who were taking the drug. Baycol is a cholesterol-lowering drug
that is classified as a statin. Baycol essentially blocks
an enzyme that creates cholesterol. In a small number of cases,
patients taking Baycol developed a debilitating muscle disease
known as rhabdomyolysis. This
disease causes deterioration in muscle tissues that can
cause severe pain and potential kidney failure. (For more
complete information about rhabdomyolysis, refer to the webpage
entitled Health
Risks.) Some 700,000 Americans were taking
Baycol when it was pulled from the market. The FDA originally
approved Baycol (cerivastatin) for the U.S. market back in
1997.Click
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There are
three high risk populations for Baycol health problems, including
older patients, patients who were taking high doses of Baycol,
and those patients taking Baycol in conjunction with gemfibrozil,
another cholesterol-lowering drug. Of the 31 deaths that have
occurred in this country, 12 involved patients who were taking
Baycol in combination with gemfibrozil. Although Baycol has
been removed from the U.S. market, it remains available in
Japan, where the doses of the drug are lower and gemfibrozil
is not available. Click
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One of the
strongest responses to the Baycol deaths has come from the
consumer advocacy group, Public Citizen. The Ralph Nader led
group claims that statins (of which Baycol is one type) are
responsible for 50 additional deaths in this country over and
beyond the deaths associated with Baycol. Publc Citizen has
strongly urged the FDA, Bayer, and others who helped to bring
Baycol to market to require the company to heighten warning
labels on cholesterol-lowering drugs that pose potentially
fatal outcomes to patients.
Specifically,
Public Citizen thinks that the FDA should force statins to
feature a black box label that points out possible adverse
side effects. In addition, they feel that patients who are
filling their prescription should be given a special medical
guide detailing health risks.
At the urging
of the FDA, Bayer announced that it would stop selling Baycol
in the U.S., although the drug will still be available in Japan.
According to the FDA, they have no plans to review the safety
of statins. Click
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Baycol
belongs to a family of drugs called statins. Statins block
one of the liver enzymes that causes cholesterol. In a small
number of cases, the statin can lead to Rhabdomyolysis, a potentially
fatal disease where muscle cells are destroyed and then released
into the blood stream. In a small number of cases, patients
can develop kidney failure. Five other statins are currently
on the U.S. market, although according to the FDA, none have
proved overly dangerous for those patients taking them. Statins,
which are taken by 8 million Americans, have made impressive
strides for the majority of patients in the treatment of high
cholesterol. Click
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The concerns
centering on the health risks associated with Baycol had been
brewing for months preceding the August withdrawal from the
market. Health and drug regulators in England banned the use
of Baycol in high doses (the Food and Drug Administration debated
taking similar actions).
Statins are
a family of drugs, including Baycol, Zocor Mevacor, Pravachol,
Lescol, and Lipitor. With the exception of Baycol, the other
statin drugs are available in the U.S. It should be noted that
all of the statins listed have been linked to muscle side effect
called rhabdomyolysis. Baycol is the one that has been associated
with fatal results. Click
Here for a Baycol Recall Lawyer Attorney!
Statins constitute
a thriving segment of the drug industry, with sales expected
to reach $25 billion in 2005. Of the entire market, Baycol
was a relatively small timer with Pfizer's Lipitor and Merck's
Zocor controlling nearly 80% of the U.S. market.
Consult with
your physician if you are taking one of more statin and experience
muscle pain or discomfort. If you are currently taking Baycol,
talk with your doctor about whether a different statin medication
is right for you. Any patient who is taking Baycol in combination
with gemfibrozil should immediately speak with your doctor
about the health risks. Click
Here for a Baycol Recall Lawyer Attorney!
Your Baycol Recall Information Source