Consumer groups unhappy with revised Crestor warning label

By Hubert Vigilla

Published on August 08, 2005

The warning label on Crestor now reads "unexplained muscle pain and weakness could be a sign of a rare but serious side effect and should be reported to your doctor right away." Both the FDA and manufacturer AstraZeneca also warn that consumers should not use Crestor combined with alcohol or certain medications. Crestor should also not be used if consumers have kidney or liver problems, are of Japanese or Chinese descent, or are nursing or pregnant.

The initial launch for Crestor was delayed when the FDA questioned AstraZeneca's clinical trials. Patients taking 80 milligrams of Crestor a day reported side effects such as kidney damage and weak muscles. Even at lower doses, reports on the side effects of Crestor showed debilitating muscle deterioration, kidney failure, and even death. These side effects pointed to potential symptoms of Rhabdomyolysis, a condition that can occur when a considerable number of skeletal muscle cells die.

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