The Pharmaceutical Journal
Vol 273 No 7308 p78
17 July 2004

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News summary

Lancet letter highlights rosuvastatin side effects

The Lancet has published a letter that highlights the adverse effects of rosuvastatin (Crestor) and calls for the drug to be removed from the market. The letter, from the US Public Citizen’s Health Research Group, points out cases of rhabdomyolysis and acute renal failure in patients treated with rosuvastatin. It adds that the risks of myopathy may increase in special populations such as those taking certain other drugs, those with renal impairment and patients of Japanese descent.

AstraZeneca, manufacturer of Crestor, claims the letter is misleading. It says that rosuvastatin is well tolerated, with very rare reports of rhabdomyolysis (<0.01 per cent). The company points out that the drug is often used inappropriately, for example, at higher start doses than are recommended or in patients with predisposing factors, and adds that proteinuria has been found to be transient.

Furthermore, changes in European prescribing information have been made for patients requiring the 40mg dose. It is now recommended only for those with severe cholesterolaemia at high cardiovascular risk and is contraindicated in those with predisposing factors for myopathy or rhabdomyolysis.