Baycol
(Cerivastatin Sodium Tablets)
History and Background
Baycol is a prescription drug produced by Bayer and
GlaxoSmithKline. It
was designed to lower cholesterol and triglicerides in the
bloodstream. Baycol is a “statin” drug, and like drugs of
this group, it inhibits the enzyme HMG-CoA reductase.
With this enzyme inhibited, cholesterol production in
the body is reduced. However,
Baycol has been shown to cause liver and kidney damage, liver
failure, and muscle degeneration in patients, thus making the
treatment far worse than the ailment.
Bayer seems to have never had a moments rest in dealing
with the problems associated with Baycol.
In December of 1999, the Bayer Corporation changed the
Baycol prescribing information to include additional
contraindicated drugs. Additionally,
health care professionals were instructed to never combine
Baycol with gemfibrozil under any circumstances.
On May 21, 2001 the Food and
Drug Administration issued a letter to Healthcare
Professionals informing them of Bayer’s voluntary change
in the prescribing information concerning Baycol.
They indicated that dosages should be lowered and
issued additional warnings reinforcing the risks associated
with myopathy and rhabdomyolysis.
Baycol was recalled by Bayer
on August 8, 2001. The
recall was due to the harmful side effects that have been
attributed to Baycol and the extreme risk that Baycol
has to patient safety.
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Legal Issues Surrounding Baycol
The FDA ordered GlaxoSmithKline and Bayer, the manufacturer of Rezulin,
to put stronger liver toxicity warnings on the drug and an
advisory committee recommended the drug be available to only a
select group of patients due to the immense risk
of harm. Additionally,
Baycol causes the condition known as rhabdomyolysis, a
disorder involving injury to the kidneys caused by toxic
effects of the contents of muscle cells. Baycol is also
responsible for a condition called myglobinuria, which occurs
when myoglobins, a tissue associated with muscle cells, is
present in the urine. These
conditions are extremely harmful and require medical
treatment. Additionally,
Baycol could have avoided these risks through proper diligence
and testing. The
warnings, as well as the eventual removal from the market
comes too late for those who have taken the drug and have
experienced the debilitating side effects of Baycol.
Side Effects and Signals
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Joint pain
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Sinus problems
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Weakness
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Muscle pain
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Increased cough
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Insomnia
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Low blood
pressure
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Unusual tiredness
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Kidney damage
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Malaise
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Red tint in urine
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Seizures
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Blood infection
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Dark urine
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Unexplained
weight gain
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Decreased muscle
mass
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Kidney Failure
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Liver Failure
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