Doctors have been warned to be vigilant in their prescribing of a cholesterol-lowering drug because of the risk of it causing serious damage to muscle.
Rosuvastatin - marketed as Crestor by the drug company Astra Zeneca - is one of the widely-prescribed statin group of drugs recommended for patients with coronary heart disease and elevated levels of cholesterol. The statins have been credited with significantly reducing death rates from heart disease.
The company, with the agreement of the Irish Medicines Board, has written to doctors here advising them of "important new safety information" and changes to prescribing advice for Rosuvastatin.
The changes have been prompted by reports of rhabdomyolysis, a condition in which the body's muscle begins to disintegrate, associated with the use of Rosuvastatin and other drugs in this class. While rare - rhabdomyolysis occurs in 1 in 10,000 taking the statin - the condition is potentially life-threatening. The breakdown products of muscle can overwhelm the kidneys, leading to kidney failure and death.
In the advisory note to doctors, the company said it was especially concerned about the "increased risk of rhabdomyolysis with doses above 20mg (a day)". A spokeswoman for Astra-Zeneca said yesterday: "We want to ensure that Rosuvastatin is used appropriately. Most people will achieve the target goal of cholesterol reduction with a 10mg dose".
the company has now advised that titration of dose to 40mg should only occur under specialist medical supervision.
Last month, there was major surprise when the Department of Health in the UK announced that it was to make statins available over-the-counter and without prescription. While the move was welcomed by the Irish Pharmaceutical Union, both GPs and cardiologists said they would be concerned if the Department of Health was to introduce a similar scheme here.
Although there have been no fatalities associated with Rosuvastatin in the Republic, The Irish Times understands there has been at least one case of rhabdomyolysis linked to the drug here.
According to a report published by the Department of Epidemiology and Public Health Medicine at the Royal College of Surgeons in Ireland this week, 73 per cent of cardiac patients discharged from hospital are prescribed statins.