Warning over popular statin’s side effects

A popular statin should not be used because there is growing evidence of side effects, a doctor and campaigner has claimed.

While the cholesterol-lowering power of rosuvastatin (Crestor) exceeds other statins, it is associated with a higher increased risk of diabetes, said Dr Sidney Wolfe.

In an opinion piece in the medical journal, BMJ, he asks: “Given the evidence of more serious risks and less clinical benefit than other statins, how has the drug fared so well for so long?”

Dr Wolfe, the founder and senior adviser to the US civil rights group Public Citizen’s Health, said the drug’s success was due to it having the best cholesterol lowering potency of all statins — a fact that was exploited in advertising campaigns.

However, in spite of its success the drug, which is licensed for the prevention of heart disease and stroke, it should have been withdrawn, he asserts.

He says Public Citizen had asked the US food and Drug Administration (FDA) to ban the drug in 2004 because of its concerns.

Irish medicines’ watchdog, the Health Products Regulatory Authority (HPRA), said it had received 169 reports of suspected reactions associated with rosuvastatin. It said most of the reports were in line with the side effects of the drug described in the product information. The side effects listed include gastrointestinal disorders, increased blood creatinine levels,abnormal liver function tests, muscle pain, weakness, cramps, and swelling.

The watchdog said it used systems where adverse reaction reports were pooled with data from other countries to provide information on global safety experience with medicine.

It said the currently approved product information includes warning about the risk of diabetes with statins, the group of medicines to which rosuvastatin belongs.

However, the product information highlights that the risk of diabetes is outweighed by the reduction in vascular risk and, therefore, should not be a reason for stopping statin treatment.

It points out that at-risk patients should be monitored by their doctors.

The product information also mentions the diabetes link with rosuvastatin use but says this is more likely to occur in patients with high levels of sugars and fats in their blood as well as other risk factors including obesity and high blood pressure.

However, Dr Wolfe concludes his argument against rosuvastatin by saying he hopes the drug’s disadvantages would lead to a sharp decline in its use before the AstraZeneca patent for rosuvastatin expired next year.

A spokesperson for AstraZeneca said it took its commitment to patient safety extremely seriously and that Crestor had a well established safety profile. It said Crestor was approved in over 109 countries and was used by tens of millions.

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