Safety
Problems Associated with
Cholesterol-lowering
Drug Crestor
 Rosuvastatin (CRESTOR)
became the sixth cholesterol lowering "statin" drug on the
U.S. market when it was approved by the Food and Drug Administration
(FDA) on August 13, 2003. The other members of the statin family are
atorvastatin (LIPITOR), fluvastatin (LESCOL), lovastatin (MEVACOR),
pravastatin (PRAVACHOL), and simvastatin (ZOCOR). These drugs are only
approved to be used along with a low-cholesterol diet and an exercise
program to lower cholesterol.
Of the approved statins,
cerivastatin (BAYCOL), was removed from the market because of at least
31 reports of fatal rhabdomyolysis, an adverse reaction involving the
destruction of muscle tissue that can lead to kidney failure.
AstraZeneca originally
filed its application with the FDA to market rosuvastatin in June 2001.
The application was delayed when the company halted clinical trials
worldwide. After reports of kidney damage and muscle weakness (an early
signal for rhabdomyolysis) in clinical trials in patients taking 80
milligrams of the drug per day, the FDA asked AstraZeneca for more
data. The company stopped development of the 80 milligram dose because
of the safety problems, and rosuvastatin will only be sold in 5, 10,
20, and 40 milligram strengths.
On July 9, 2003, Public
Citizen petitioned the FDA to withhold approval of rosuvastatin because
of its unique potential to cause kidney toxicity. In the FDA review
documents posted on the agency's website before the Endocrinologic
and Metabolic Drugs Advisory Committee it was noted "In contrast
to currently approved statins, rosuvastatin was also associated with
renal [kidney] findings not previously reported with other statins."
If you or a loved
one believe that they have been harmed by Crestor, we can help. When it
comes to dangerous drugs, Fonvielle Lewis Foote and Messer represents
clients throughout the United States. We can assist you wherever you
live. For more information, please call us at (800) 876-7773 or print,
complete, and mail the CRESTOR
Questionnaire
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