|
Baycol (cerivastatin) is made by Bayer
Pharmaceutical Division.
On August 8, 2001 , the FDA (Baycol
info. page) 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.
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.
Baycol, 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.
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 shoulddiscontinue Baycol immediately
and consult their physician.
Baycol Links
MDL 1431 — Baycol Product Liability Litigation
Federal Court Orders Expedited Case Management Schedule in Baycol
Products Litigation, MDL 1431
CNN.com — Bayer: Baycol anti-cholesterol drug linked to
52 deaths
Bayer Facing 7400 Baycol Suits
Cholesterol drug damaged woman, she says
Bayer Facing 7400 Baycol Suits
Bayer faces more suits
Germany's Bayer Faces Drug Lawsuits
More Class Action Lawsuit Information:
Each year in Texas, and throughout the United States, millions
of people are injured through the negligence of companies that
release unsafe or defective products. If you have used or been
exposed to any of these products, we can help. There are statutes
of limitations involved in Texas class actions, so contact us as
soon as possible to protect your rights!
Jeff Rasansky is licensed to practice before all state courts
in Texas, the United States District Courts in the Northern and
Eastern Districts of Texas and the Fifth United States Circuit
Court of Appeals.
Click here to contact
The Rasansky Law Firm.
|
