Statin and ticagrelor drug interaction increases risk of rhabdomyolysis

Excerpt

A drug interaction between statins (HMG-CoA reductase inhibitors) and ticagrelor appears to increase the risk of rhabdomyolysis, advises the Malaysian National Pharmaceutical Regulatory Agency (NPRA).In Malaysia, there are currently 60 products containing atorvastatin, 47 containing rosuvastatin and 39 containing simvastatin registered with the Drug Control Authority.Statin-induced rhabdomyolysis is a widely known adverse event, says the NPRA, and the risk increases when statins are used concurrently with drugs that elevate their concentrations.The NPRA was informed that the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency reviewed available data on the risk of rhabdomyolysis associated with the drug interaction between rosuvastatin and ticagrelor, and concluded that this interaction resulting in rhabdomyolysis was established, and that product information for rosuvastatin-containing products should be updated accordingly.To date, the NPRA has received local reports of rhabdomyolysis associated with simvastatin (46 reports), atorvastatin (13) and rosuvastatin (3), but none were linked to drug interactions with ticagrelor. The NPRA has also received reports of myopathy associated with simvastatin (35), atorvastatin (10) and rosuvastatin (1), but none involved drug interactions with ticagrelor. There have been no spontaneous reports involving rhabdomyolysis or myopathy locally or globally involving concurrent use of ticagrelor and any registered statins.Healthcare professionals are advised that statin-induced rhabdomyolysis is dose-dependent, and co-administration of ticagrelor and a statin is generally safe at routinely prescribed doses. Patients should consult their doctor if they experience muscle pain, tenderness, or weakness that persists or worsens, particularly during the initiation of combination therapy or during upward dosage titration of either drug.All adverse events suspected to be related to the use of statins and ticagrelor in Malaysia should be reported to the NPRA. …