Several approaches may be taken to decrease the risk of a drug safety hazard. Within its regulatory purview, the Food and Drug Administration can request changes in product information including Warnings and Precautions to educate or remind physicians of drug risk, risk factors, and recommendations to decrease risk. The highest level of drug warning is the boxed (“black box”) warning, which is appropriate for bleeding due to warfarin use because of its prevalence and serious consequences. A Medication Guide aimed at educating and reminding patients about the risk of bleeding with warfarin use and actions they can take to decrease this risk is also appropriate. While Medication Guides have acknowledged weaknesses including unknown or poor reading rates and, in some cases, poor reader comprehension, they are meant to aid rather than replace discussions between health practitioners and patients about the drug's safe use. The Medication Guide can reinforce the “take home message” and can serve as a handy reference should a safety concern arise.
In addition to the updated product information and Medication Guide, other sources of information, such as those available to Internet users, and other initiatives exist that are or may prove to be useful in decreasing the risk of serious bleeding with warfarin use. These include the establishment and use of anticoagulant clinics for monitoring the prothrombin time/international normalized ratio,1 patient monitoring of anticoagulation,2 and the identification of patients at increased risk of bleeding through risk factor identification and genetic testing for CYP2C9 and VKORC1.3,4 Recently, pharmacogenomic information has been added to the product information for warfarin.5
While it is difficult to prove the individual effectiveness of black box warnings and Medication Guides, we believe that these initiatives, along with other interventions, will help decrease the prevalence of serious bleeding associated with warfarin use.6
Correspondence: Dr Wysowski, Office of Surveillance and Epidemiology, Food and Drug Administration, Silver Spring, MD 20993 (firstname.lastname@example.org).
Disclaimer: The views expressed are those of the author and do not necessarily represent the official position of the Food and Drug Administration.
Wysowski DK. Bleeding Associated With Warfarin Use: Improving Outcomes—Reply. Arch Intern Med. 2008;168(2):237. doi:10.1001/archinternmed.2007.50