London: Higher doses of cholesterol lowering drug Zocor, sold generically as simvastatin, may increase risk of a condition which can lead to fatal kidney failure, a drug watchdog has warned.
According to an analysis of clinical trial data in America, large doses of simvastatin, which is taken in order to lower cholesterol and reduce the risk of having a heart attack, can cause muscle damage and a rare condition which induces kidney problems and may be fatal.
Patients were told not to stop taking simvastatin but advised to talk to their doctor if they have concerns, reports The Telegraph.
The US medicines regulator, the Food and Drug Administration, has issued a warning to patients to be alert to signs of problems when taking the 80mg daily dose of simvastatin.
A spokesman for the Medicines and Healthcare products Regulatory Agency said: "The 80 mg per day dose is only recommended in patients with severe hypercholesterolaemia and at high risk for cardiovascular complications.
"Myalgia (complaints of muscle aches) is a common side effect of statins, including simvastatin. It is recognised that very rarely statins can cause more serious muscle damage (myopathy) which in some cases may be life-threatening.
"There are comprehensive warnings in the product information for prescribers and in the Patient Information Leaflet.
"These warnings advise that the risk of muscle injury is greater: at higher doses of simvastatin; when used in combination with certain other medicines including amiodarone (a medicine used for an irregular heart beat) and other medicines that are recognised to increase the risk of myopathy; and in certain patient groups including those who are more than 70 years old, those with kidney or thyroid problems, those who consume large amounts of alcohol, and those with a history of previous muscle problems during treatment with statins or other lipid lowering drugs.
"As with all marketed medicines the safety of simvastatin is kept under continuous review by the MHRA."