Pharmacovigilance Newsletter June 2010

Anonymous

460-377 BC Hippocrates’ Primum non nocere, "First do no harm"

Dear fellow healthcare professional,

Thank you for the warm & positive response to the newsletters. Many thanks to those persons who have submitted adverse drug reaction (ADR) reports. Please continue to do this as these reports will help us to, among other things, determine the prevalence of ADRs in the Jamaican population. The data collected is submitted to the Ministry of Health(MOH) using the "PharmWatch" form. In turn the MOH inserts the information into VIGIFLOW, the WHO’s database of ADRs from around the world.

Our second workshop "Pharmacovigilance, ensuring the safe use of medicines: The role of healthcare professionals in adverse drug reaction reporting " was held on May 16, 2010 in the Main Lecture Theatre, UHWI. Thanks to the participants (pharmacists, physicians, dentists) & our sponsors –Roche Pharmaceuticals, Novartis, Dr. Reddy’s Laboratories & Astra Zeneca.

Increased risk of muscle injury with high

doses of Simvastatin.

The FDA warned health-care professionals & patients that there is an increased risk of myopathy in patients taking the highest approved 80 mg dose of simvastatin compared to patients taking lower doses of simvastatin & possibly other statins. The most serious form of myopathy is rhabdomyolysis , a rare adverse event reported with all statins. The risk of myopathy is increased when simvastatin, especially @ higher doses, is used with certain drugs. The FDA recommends that Itraconazole ,Ketoconazole, Erythromycin ,Clarithromycin ,Telithromycin, HIV protease inhibitors & Nefazodone are not used with simvastatin due to potential drug-drug interactions. They also recommended that - Gemfibrozil ,Cyclosporine ,Danazol - not be used with more than 10mg of Simvastatin. Amiodarone & Verapamil must not be used with more than 20mg of Simvastatin. Diltiazem should not be used with more than 40mg of Simvastatin.

Reference: Safety Information, US FDA 19 March 2010 (www.fda.gov).

We all have a role to play in making drugs safe to use.

Best Regards,

Dr. Jacqueline E. Campbell.