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Why was Baycol recalled?
Baycol is part of a class of drugs called statins. While all statins have
been linked to the rare and life-threatening condition rhabdomyolysis, Baycol
showed a significantly higher amount of rhabdomyolysis occurrence. Over
one hundred deaths have been due to rhabdomyolysis and the use of Baycol,
in addition to the belief that hundreds of other Baycol patients have suffered
from rhabdomyolysis attacks.
Are other statins safe to use?
After the FDA Baycol recall on August 8, 2001, Public Citizen petitioned
the FDA to add a black box warning on the remaining statins still available,
the strongest warning issued. The Baycol recall prompted other statin users
to also discontinue their use of the cholesterol-lowering drug.
What is rhabdomyolysis?
Rhabdomyolysis is a very rare condition where serious muscle damage results
in release of muscle cell contents into the bloodstream. Rhabdomyolysis
may result in kidney damage and other organ damage which may be fatal. All
statins have been associated to the risk of rhabdomyolysis but Baycol was
found to have a much higher occurrence. At the time of the Baycol recall
there had been around 100 reported deaths due to rhabdomyolysis.
How do I know if I am having this serious reaction (rhabdomyolysis)
to Baycol or other statins?
Patients who develop rhabdomyolysis often have muscle aches involving their
calves, back, or their entire body. The pain may be accompanied by weakness,
fever, nausea, vomiting, and passing of dark urine.
What should I do if I think I''m suffering from the life-threatening
condition rhabdomyolysis?
Immediately discontinue the use of the drug and call your physician.
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. At the time of the Baycol recall there were 700,000
Americans using the drug.
Will I have any problems if I immediately discontinue the use of Baycol
or other statins?
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. When stopping a prescription medication it is advised to consult
with your physician to discuss alternative therapies.
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.
An editorial in the Journal of the American Medical Association is one of just several articles to appear in next week’s edition that focuses on the FDA’s ability to effectively monitor drug safety. Following the September Vioxx recall, more critics h...
Bayer''s Baycol cholesterol drug was recalled in August 2001 and is now linked to over 100 deaths. The company has so far paid $842 million to settle 2,224 cases but still faces 9,948 more Baycol cases. Now the company is facing a class action in Penns...
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