Post-approval adverse events of new and old anticoagulantsBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g1859 (Published 06 March 2014) Cite this as: BMJ 2014;348:g1859
- Keith B Hoffman, vice president, scientific affairs1,
- Andrea Demakas, analyst1,
- Colin B Erdman, technical lead1,
- Mo Dimbil, senior analyst1
- 1AdverseEvents, Santa Rosa, CA 95403, USA
Anticoagulants are some of the most widely used drugs worldwide. Dabigatran is commonly assumed to be safer than warfarin, but because debate continues on this question,1 we analysed post-marketing safety signals across this drug class.
Drug safety analysis is often enhanced by identifying links between a given drug and a group of adverse events. The Medical Dictionary for Regulatory Activities and the Council for International Organization of Medical Sciences created and validated categories of related adverse events known as “standardised queries.”2 These groupings help improve signal detection from adverse event case reports contained in the Food …