Wysowski et al1 reviewed the prevalence of bleeding complications associated with the use of warfarin sodium for the implementation of a “black box” warning and Medication Guide. These are not appropriate solutions to decrease bleeding adverse events. While the addition of black box warnings to package inserts can be a useful tool for many medications, the information contained in the warning for warfarin is considered general knowledge. It will not affect current practice.
Barkell M. Bleeding Associated With Warfarin Use: Improving Outcomes. Arch Intern Med. 2008;168(2):236-237. doi:10.1001/archinternmed.2007.46