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Brilinta (Ticagrelor) & Concomitant Use with Lipitor (Atorvastatin) or Crestor (Rosuvastatin)

    Basic Details
    Last Updated
    Monday, September 13, 2021
    Original Posting Date
    Health Outcome(s)
    concomitant use with Lipitor (atorvastatin) or Crestor (rosuvastatin)
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    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.