The FDA maintained its position on the safety of the anticoagulant dabigatran after completing a study that included an older patient population. Based on the results, the agency said it would make no changes in its recommendations or to the labeling.
The FDA study compared dabigatran (Pradaxa, Boehringer Ingelheim) with warfarin in 134,000 Medicare patients to assess its risk in an elderly population. The FDA concluded that in new users, dabigatran was associated with a lower risk of ischemic stroke, brain hemorrhage and death compared with warfarin but had an increased risk of major gastrointestinal bleeding and a similar risk for MI.
Dabigatran was approved in 2010 to reduce the risk of stroke in patients with nonvalvular atrial fibrillation, based on results from the clinical trial RE-LY (Randomized Evaluation of Long-term anticoagulation therapY). The study showed dabigatran to be noninferior to warfarin, with lower rates of major hemorrhage with the 110 mg dose and similar rates of major hemorrhage with the 150 mg dose. The rate of MI was higher than warfarin for both doses.
The FDA has come under fire for its position on dabigatran’s safety profile. Based in its Mini-Sentinel program, the FDA previously concluded that dabigatran was equivalent to warfarin for bleeding risks.
“[T]he new study is based on a much larger and older patient population than those used in FDA’s earlier review of post-market data, and employed a more sophisticated analytical method to capture and analyze the events of concern,” the FDA wrote in a drug safety communication. “This study’s findings, except with regard to MI, are consistent with the clinical trial results that provided the basis for Pradaxa’s approval.”