Baycol Information

    Baycol®, the brand name of cerivastatin sodium, was a
prescription drug used to lower cholesterol in patients who could
not control their cholesterol levels through diet and exercise alone.
Baycol® was sometimes prescribed to be taken with other
cholesterol-lowering medications for a stronger effect.

    The FDA and the Bayer Corporation have had concerns about
Baycol's® safety since 1999. On August 8, 2001, the Bayer
Corporation, the company that manufactured and sold Baycol®,
voluntarily took Baycol® off the market. According to FDA reports, at
least 31 deaths have been associated with Baycol® use. In some
patients Baycol® causes a muscle cell condition called
rhabdomyolysis in which muscle cells breakdown, rupture and
release muscle cell proteins and pigments into the bloodstream
that cause kidney damage and in some cases, even kidney failure
and death. It also appears that Baycol® was particularly dangerous
when it was prescribed to be taken with other cholesterol-lowering
medications, especially Lopid® (gemfibrozil). However, Baycol®’s
dangerous side effects were also seen more often when Baycol®
was prescribed with other medications such as niacin, certain
antibiotics and certain antifungal medications.

    Symptoms of the muscle cell problem, rhabdomyolysis, one of
Baycol®’s dangerous side effects, include muscle pain and
weakness, general fatigue, fever, nausea and vomiting, and dark
and discolored urine (reddish, rose, or cola colored urine).
Rhabdomyolysis causes the blood serum levels of plasma
creatine kinase (ck) levels to be very high. Acute kidney failure can
occur and can cause death. The diagnosis of the problems
associated with Baycol® may have been difficult for the patient's
physician. For this reason, there may be many undiagnosed
deaths from acute kidney failure associated with Baycol®. There
may also be some patients who suffer chronic muscle problems
related to their use of Baycol®.