Crestor Dear Doctor Letter Sent to UK Doctors

Letter Follows 4 New Rhabdomyolysis Cases

In May 2004, AstraZeneca sent a Dear Doctor letter to UK health professionals urging them to recommend the 10 mg dose for new patients when prescribing Crestor. The letter was sent voluntarily by AstraZeneca following reports of 4 new rhabdomyolysis cases, a muscle toxicity condition which can lead to kidney damage. Rhabdomyolysis is a relatively rare disorder involving injury to the kidney caused by toxic effects of the contents of muscle cells. When the skeletal muscle is damaged, an iron-containing pigment found in the skeletal muscle, known as myoglobin, is released into the blood stream. Myoglobin is filtered out of the blood stream by the kidneys, but the process may occlude the structures of the kidney and cause acute renal failure secondary to myoglobinuria.

The letter advised health care professionals that patients should not be started initially on the higher doses of Crestor; however, a US consumer advocacy group Public Citizen said it has obtained new data showing that seven US patients taking the 10 mg dose experienced rhabdomyolysis.

The rate of adverse drug reactions is consistent with the side effect profile seen in statin drugs, particularly the ill fated statin Baycol, which was taken off the market in 2001 after reports of rhabdomyolysis, kidney failure, kidney damage, and death. Other statins have been linked to the life-threatening condition rhabdomyolysis, and Crestor appears to be no exception.

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