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Crestor Information
Crestor has been associated with the following adverse side effects, according to the Public Citizen's latest petition:
7 patients with rhabdomyolysis
4 patients with acute kidney failure
5 additional patients with kidney damage
6 patients with bleeding or abnormal bleeding tests who were also using blood thinning drugs such as coumadin
In addition, the Public Citizen reports that the FDA has received 65 reports of rhabdomyolysis and 29 cases of acute renal failure or renal insufficiency out of 4.5 million Crestor prescriptions, which is similar to the rate associated with Baycol.
Crestor, known generically as Rosuvastatin, was approved by the Food and Drug Administration (FDA) on August 14, 2003 for the treatment of high-cholesterol. Manufactured by AstraZeneca, Crestor reduces cholesterol levels by blocking the liver from producing bad cholesterol (LDL). Crestor became the sixth cholesterol lowering "statin" drug on the U.S. market, following drugs like Lipitor, Pravachol and Zocor.
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Only three months after its approval, three patients in the United
States who were taking approved doses of rosuvastatin developed
Crestor side effects, including kidney failure or muscle damage. As
in the case with Baycol, a cholesterol-lowering medicine withdrawn
from the market by Bayer due to its serious side effects in August
2002, the muscle damage, known as rhabdomyolysis deteriorates
the kidneys.
The Public Citizen filed a petition to the FDA just months after
Crestor's approval in an effort to prevent Crestor from being sold
due to concerns over kidney toxicity. In studies before Crestor's
approval, seven people were struck by cases of rhabdomyolysis.
Since the original Public Citizen petition was filed with the FDA in
early March, the organization said, eleven additional cases of
muscle damage, ten of them in the United States, and three
additional cases of kidney problems, have been reported.
Symptoms of rhabdomyolysis and kidney damage 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.
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