Statin, Baycol, and Rhabdomyolysis Questions
On August 8, 2001, Baycol was taken off the market. The FDA
provided questions and answers about Baycol, the statin drug
intended to lower cholesterol for the 700,000 Americans taking
Baycol at that time. Baycol
side effects include the serious and potentially fatal
condition rhabdomyolysis.

CONTENTS
What should I do if I am taking
Baycol?
What should I do if I am taking Baycol and gemfibrozil
(Lopid)?
What is rhabdomyolysis?
How do I know if I am having this serious reaction
(rhabdomyolysis) to Baycol?
What should I do if I think Im having this
reaction (rhabdomyolysis) to Baycol?
What is Baycol used for?
Will I have any problems if I stop Baycol?
Are there any alternatives to Baycol?
Do the other statins have the same safety concerns
as Baycol?
Who can I contact for more information on Baycol?
What should I do if I am taking Baycol?
If you are taking Baycol, contact your physician to discuss
alternative medications. If you are taking Baycol and experience
muscle pain, discontinue Baycol immediately and contact your
physician for further advice.
What should I do
if I am taking Baycol and gemfibrozil (Lopid)?
If you are taking Baycol and gemfibrozil (LOPID), discontinue
the Baycol immediately and contact your physician for further
advice.
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What is rhabdomyolysis?
Rhabdomyolysis
is a very rare condition where serious muscle damage results
in release of muscle cell contents into the bloodstream. On
very rare instances, rhabdomyolysis may result in kidney damage
and other organ damage, which may be fatal.
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How do I know if
I am having this serious reaction (rhabdomyolysis) to Baycol?
Patients who develop rhabdomyolysis often have muscle aches
involving their calves, back, or their entire body. Weakness,
fever, nausea, vomiting, and passing of dark urine may accompany
the pain.
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What should I do
if I think Im having this reaction (rhabdomyolysis)
to Baycol?
Stop the drug immediately and call your physician.
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What is Baycol used
for?
Baycol is a cholesterol-lowering drug belonging to a class
of drugs known as statins.
It is prescribed to reduce your cholesterol and to reduce
your risk of heart disease.
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Will I have any
problems if I stop Baycol?
If you were prescribed Baycol to lower your cholesterol, these
levels may go back to where they were before you received
the drug. These changes will not occur immediately but will
most likely occur over a couple of days to weeks. If you stop
Baycol, be sure to consult your physician to discuss alternative
therapies for lowering your cholesterol.
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Are there any alternatives
to Baycol?
There are five (5) other drugs in the same class (statins)
available in the U.S. market. They are atorvastatin (Lipitor),
fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol),
and simvastatin (Zocor). There are also other drugs approved
for lowering cholesterol that are not statin drugs. You should
consult you physician to determine which treatment is right
for you.
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Do the other statins
have the same safety concerns as Baycol?
All statins
have been associated with very rare reports of rhabdomyolysis.
These rare cases can occur when the drugs are used alone or
in combination with another lipid-lowering drug such as gemfibrozil.
However, cases of fatal rhabdomyolysis in association with
Baycol use have been reported more frequently than other approved
statins.
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Who can I contact
for more information on Baycol?
Please contact
us if you would like to receive more information on Baycol
side effects.
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