Boxed Warnings in Dermatotherapeutics

Boxed warnings (BWs), more commonly known as ‘Black Box warnings,’ are safety-related warnings assigned to medications by the Food and Drug Administration of the United States of America. Adverse events of the most serious kind and new data that emerged through post-marketing surveillance are highlighted. Furthermore, they implore the physician to pay heed to other important matters such as dosing, monitoring protocols as well as probable drug interactions. In the prescribing information document for any drug, special emphasis is placed on the BW by highlighting it with a black border and placing it on the top of the list of adverse drug reactions (ADRs). Commonly prescribed systemic medications for which BWs have been issued include azathioprine, itraconazole, cyclosporine, ciprofloxacin, tofacitinib, oral retinoids and rituximab. BW related to topical calcineurin inhibitors generated a lot of debate. The issues and challenges related to BW include financial and marketing aspects, undue apprehension in the minds of physicians and patients, medicolegal aspect. The onus is on the physician to be aware of such a warning and to assess the risks versus benefits before prescribing such drugs. Participation of the physician in post-marketing surveillance is essential in knowing about previously unknown ADRs. Through this article, the idea that these BWs are not to be viewed as complete contraindications but as an important guiding tool that should not be ignored has been explored.