Details
This analysis provided information on concomitant utilization of ticagrelor and moderate/high-intensity statins. FDA received postmarket reports of statin-induced myopathy/rhabdomyolysis in elderly patients taking atorvastatin or rosuvastatin with ticagrelor. Considering that use of high-intensity statins is advised in secondary prevention following a myocardial infarction, FDA initiated this analysis to understand utilization patterns for patients concurrently taking ticagrelor and a statin and provide context for postmarket case reports. Our Sentinel analysis found that out of all ticagrelor 90mg exposures in patients ≥75 years, the proportion of concomitant use with high-intensity statins increased from 57% in 2012 to 66% in 2016. Based upon these data and analyses from other sources, FDA decided that no regulatory action was needed at this time.