IMB Statement on Atorvastatin and Fusidic Acid- Ireland

Title:IMB Statement on Atorvastatin and Fusidic Acid

Product:Atorvastatin and Fusidic Acid

Active Substance:Atorvastatin and Fusidic Acid

Issue:The Irish Medicines Board (IMB) is aware of the inquest that was conducted yesterday (07/08/8) in Cork into the death of 58 year old man, who developed rhabdomyolysis (an extremely rare, but very serious condition causing severe muscle and kidney damage), following treatment with atorvastatin, a cholesterol lowering medicine and fusidic acid, an antibiotic

Muscle disorders ranging from muscle weakness, cramp and pain to more severe forms of muscle disorders are well known adverse effects of treatment with atorvastatin and other medicines that lower cholesterol, commonly known as “statins”, both when these medicines are used alone, or in combination with other treatments. Information on the risk of muscle disorders is described in the product information (i.e. the Summary of Product Characteristics [SPC] for healthcare professionals, and the package leaflet [PL] for patients/caregivers) for the individual medicines and the IMB has also issued warnings regarding this risk and recommendations for monitoring in a number of its publications, most recently in the January 2008 issue of its Drug Safety Newsletter.

Information on the risk of muscle disorders associated with concurrent atorvastatin treatment and some antibiotics is included in the product information, with warnings and advice regarding such use. To date, the IMB has received three reports of suspected interaction between atorvastatin and fusidic acid and is currently reviewing these cases, together with other available data to assess the need for further regulatory action

Action to be taken:The outcome of the IMB review will be communicated when completed. In the meantime, the IMB considers that the benefits of treatment with atorvastatin outweigh its potential risks in the majority of cases. Healthcare professionals and patients/caregivers are advised to carefully read the product information, closely follow the current recommendations and if patients/caregivers have any concerns regarding any aspects of their treatment, they should discuss these with their doctor or pharmacist.