Baycol Recall
Baycol Recall FDA Announcement
-From the FDA Talk Paper
August 8, 2001
| BAYER VOLUNTARILY
WITHDRAWS BAYCOL |
FDA today announced 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.
Baycol (cerivastatin), which was initially approved in the
U.S. in 1997, is a member of a class of cholesterol lowering
drugs that are commonly referred to as "statins."
Statins lower cholesterol levels by blocking a specific enzyme
in the body that is involved in the synthesis of cholesterol.
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.
Fatal rhabdomyolysis
reports with Baycol have been reported most frequently when
used at higher doses, when used in elderly patients, and particularly,
when used in combination with gemfibrozil (LOPID and generics),
another lipid lowering drug. FDA has received reports of 31
U.S. deaths due to severe rhabdomyolysis associated with use
of Baycol, 12 of which involved concomitant gemfibrozil use.
Rhabdomyolysis is
a condition that results in muscle cell breakdown and release
of the contents of muscle cells into the bloodstream. Symptoms
of rhabdomyolysis include muscle pain, weakness, tenderness,
malaise, fever, dark urine, nausea, and vomiting. The pain
may involve specific groups of muscles or may be generalized
throughout the body.
Most frequently the involved muscle groups are the calves
and lower back; however, some patients report no symptoms
of muscle injury. In rare cases the muscle injury is so severe
that patients develop renal failure and other organ failure,
which can be fatal.
Bayer Pharmaceutical Division has announced plans to withdraw
Baycol to the pharmacy level. Pharmacies will be instructed
to return the product to the manufacturer for a refund.
Patients who are taking Baycol should consult with their physicians
about switching to alternate medications to control their
cholesterol levels. Patients taking Baycol who are experiencing
muscle pain or are also taking gemfibrozil should discontinue
Baycol immediately and consult their physician.
There are five other statins available in the U.S. that may
be considered as alternatives to Baycol. They are:
- lovastatin (Mevacor)
- pravastatin (Pravachol)
- simvastatin (Zocor)
- fluvastatin (Lescol)
- and atorvastatin (Lipitor).
For further information regarding the withdrawal of Baycol,
patients and physicians can contact Bayer Customer Service 1-800-758-9794
or the FDA's Drug Information Office at 301-827-4573
or
1-888-INFO-FDA, or go to "Baycol
Information" on FDA's Website.
If you have taken Baycol and would
like to speak to a Baycol lawyer contact us
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