Postmarket Assessment for Drugs and Biologics Used in Dermatology and Cutaneous Adverse Drug Reactions

Dermatologists should become more familiar with the regulatory reporting processes for ensuring the continued safe use of approved drugs because of the increase in new drugs approved for dermatologic conditions, approvals for novel drugs with unique mechanisms indicated for nondermatologic conditions where a dermatologist may be consulted for drug-induced adverse events, the common occurrence of CADR, and the rarity of Severe Cutaneous Adverse Reactions. Because dermatologists play a key role in differentiating different types of CADR and in identifying the likely culprit drug in the clinical setting, dermatologists can have a large impact on patient safety through spontaneous reporting of suspected adverse event-drug combinations to the FDA.