Safety advice on particular drugs or classes of drugs
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| The United States: FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs including - the routine periodic monitoring of liver enzymes is replaced with assessment of liver enzymes before starting statin therapy, reports of non-serious and reversible cognitive side effects and increased blood sugar and glycosylated hemoglobin (HbA1c) levels |
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FDA has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels. Information about the potential for generally non-serious and reversible cognitive side effects and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels. The lovastatin label has been extensively updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury. Healthcare professionals should perform liver enzyme tests before initiating statin therapy in patients and as clinically indicated thereafter. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment, therapy should be interrupted. If an alternate etiology is not found, the statin should not be restarted. Healthcare professionals should follow the recommendations in the lovastatin label regarding drugs that may increase the risk of myopathy/rhabdomyolysis when used with lovastatin.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm293670.htm
In Hong Kong, there are a total of 241 registered pharmaceutical products which belong to the class of statins, among them 11 products contain lovastatin. All are prescription-only medicines. In view of FDA's recommendation, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, February 29, 2012
Issued at HKT 12:30 |
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