1. March 2012 14:12
The FDA has requested label changes for Lipitor and other statins to warn of an increased risk of diabetes and cognitive effects.
Pfizer’s Lipitor (atorvastatin), AstraZeneca’s Crestor (rosuvastatin) and Merck’s Zocor (simvastatin) are among the ‘blockbuster’ drugs to carry new warnings.
Statins, which lower blood cholesterol levels, are widely prescribed to help prevent cardiovascular events, but concern over their possible side-effects has been rising for years.
The new label changes were prompted by studies showing that patients treated with statins may be at a slightly higher risk of developing type 2 diabetes and/or cognitive symptoms including mild confusion and memory loss.
According to the FDA, the reported cognitive effects in some patients have been successfully reversed by discontinuing statin use.
The new statin labels have also removed the warning that liver enzyme levels in patients taking the drugs should be routinely monitored, as later evidence has shown this to be a rare and unpredictable side-effect.
The indications now recommend liver enzyme tests before starting statin therapy, with follow-up tests only if there is evidence of liver damage.
“The value of statins in preventing heart disease has been clearly established,” said Dr Amy Egan, Deputy Director for Safety in the FDA’s Division of Metabolism and Endocrinology Products. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”