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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. Baycol is an anti-cholesterol drug linked to disabling
rhabdomyolysis .
What
is Baycol?
Baycol is an
anti-cholesterol drug linked to disabling 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. The FDA announced on August 8, 2001 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.
Side
Effects
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.
In early August
2001, German drug manufacturer Bayer AG pulled Baycol from the market.
Baycol was withdrawn from the market because iit has been linked to
31 US deaths from a muscle-related side effect, according to the US
Food and Drug Administration. Baycol was approved in the United
States by the FDA in 1997.
The FDA had received
reports of Baycol patients experiencing severe rhabdomyolysis. Rhabdomyolysis
is a condition that causes muscle-cell breakdown (atrophy) and causes
muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea
and vomiting.
FDA announced
on August 8, 2001 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.
In a Reuters
article the FDA claimed that in some cases, rhabdomyolysis is so severe
that patients develop failure of the kidney or other organs, which can
be fatal. The FDA has stated that it has received reports of 31 deaths
associated with Baycol. This number is expected to increase as information
about Baycol's side effects have been to surface.
It is important
for you to speak with your physician about any adverse effects associated
with Baycol usage and to discuss alternative medications.
Questions
and Answers about Baycol
- 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 I’m 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?
If you believe
you have been injured by Baycol please contact us at baycol@toxicdiscovery.com |
