A summary of the FDA public health advisory for Crestor

Crestor side effects

Crestor, a cholesterol lowering drug which is a member of the class referred to as "statins", was approved for prescription in the US by the FDA in August 2003. At that time, a certain group of patients were identified as being at a higher risk of Myopathy/Rhabdomyolysis.

Myopathy / Rhabdomyolysis is a known side effect of all of the statins. It is a condition whereby the skeletal muscle is broken down due to injury of the muscle tissue. The destruction of the muscle leads to by-products, such as myoglobin, which can enter the blood system, and cause kidney damage, possibly leading to kidney failure.

The risk to the general population of rhabdomyolysis is small. According to Wikipedia, the risk is 0.44 cases per 10,0000 per year. However, this does increase to 5.98 cases per 10,000 per year if the statin is prescribed in conjunction with a fibrate. The only statin known to dramatically increase the risk of rhabomyolysis was Cerivastatin, which was withdrawn in 2001.

The original labelling of Crestor stated that the following groups of patients were at a higher risk of rhabdomyolysis than the general population:

In addition the risk of Rhabdomyolysis increases with dose. Doctors are warned to prescribe Crestor with caution in the above patient groups, especially at higher doses.

Also certain other groups of patients, including those of Asian origin or those taking cyclosporine or gemfibrozil, were at an increased risk of Rhabdomyolysis as increased levels of Crestor were seen in their blood.

Originally, Crestor was only available in 10mg, 20mg and 40mg tablets. But in view of these findings, the FDA asked Astra-Zeneca to make 5mg dose available for use in patients who were taking cyclosporine or for other reasons required a less agressive treatment. The maximum recommended dose for patients with severe renal impairment or those who are taking gemfibrozil is 10mg.

The FDA states that all patients should be informed that statins can cause injury to muscles, which in rare cases can cause kidney damage, other organ failure and death. Patients should promptly report to their doctors any of the following symptoms:

 


 

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