FDA Says Withdrawn Bayer Drug
Linked to 31 Deaths
WASHINGTON (Reuters / August 8, 2001) - Bayer AG's cholesterol drug
Baycol, which the German drug giant pulled from the market Wednesday,
is linked to 31 US deaths from a muscle-related side effect, according
to the US Food and drug Administration (FDA).
(Editors Note: Baycol was due to generate sales of over $875 million
this year. A long known side effect of this class of cholesterol lowering
drugs is the depletion of the essential nutrient Coenzyme Q10 in heart
muscle cells. For over 15 years pharmaceutical companies held and continue
to hold patents to add Q10 to cholesterol lowering drugs to avoid this
long known side effect, but refused until today to use it.) The
FDA said it agreed with Bayer's decision to voluntarily withdraw the
drug from the market. Baycol, part of class of cholesterol drugs called
statins, was approved in the United States in 1997.
The agency said it received reports of Baycol patients experiencing
severe rhabdomyolysis, a condition that results in muscle-cell breakdown
and causes muscle pain, weakness, tenderness, malaise, fever, dark urine,
nausea and vomiting.
In some cases, rhabdomyolysis is so severe that patients develop failure
of the kidney or other organs, which can be fatal, the FDA said.
``FDA has received reports of 31 US deaths due to severe rhabdomyolysis
associated with use of Baycol,'' the agency said in a written statement.
Twelve of the 31 deaths involved patients taking another drug, gemfibrozil,
the FDA said.
``While all statins have been associated with very rare reports of rhabdomyolysis,
cases of fatal rhabdomyolysis in association with the use of Baycol have
been reported significantly more frequently than for other approved statins,''
the FDA said.
Baycol patients who are experiencing muscle pain or are also taking
gemfibrozil should discontinue Baycol immediately and consult their physician,
the FDA said. Others taking Baycol should talk to their doctors about
switching to alternative medications, the agency advised.
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