It sounds like toothpaste but, if its critics are to be believed, it’s more likely to polish you off. Crestor (rosuvastatin) is one of the newest of the statins, the cholesterol drugs – but its commercial life could be short if campaigners in the States have their way.
They claim that at least two people have already died while on the drug, and a further 50 have suffered serious adverse effects, most significantly rhabdomyolysis, or muscle weakening.
Rhabdomyolysis is a problem with all of the statins, but campaigners, led by Dr Sidney Wolfe of Public Citizen’s Health Research Group, claim that Crestor’s potential for causing the condition is greater than with the other statins.
Dr Wolfe has petitioned the US’s drug regulator, the Food and Drug Administration (FDA), to ban Crestor. ‘Crestor is inherently dangerous and it should not be used. Crestor has unique risks because of its effects on the muscles and the kidneys,’ he said.
Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, fever, dark urine, nausea and vomiting. In severe cases it can cause kidney failure. Primary kidney failure occurs when the medication directly damages the organs. Secondary damage occurs when proteins released during muscle breakdown infiltrate the kidneys, Dr Wolfe explained.
AstraZeneca, manufacturer of Crestor, which received approval only last year, stoutly defend the drug. They claim that Dr Wolfe is being alarmist, and is not interpreting the data properly.
Dr Wolfe’s concerns about the drug go back to before it was approved. He appeared before an FDA panel that was considering the drug’s safety based on early, pre-licence clinical trials.
Dr Wolfe may not be a lone voice. The Canadian health authorities have advised patients to take only the lowest dose of Crestor following eight cases of muscle deterioration reported to them.
The UK drug regulators remain as wise as Solomon and as silent as the grave.