What is black box warning and what does it mean?
According to the FDA, “A black box warning is the most serious warning placed in the labeling of a prescription medication. Advertisements that serve to remind health care professionals of a product’s availability (so-called ‘reminder ads’) are not allowed for products with black box warnings.” For consumers, a black box warning indicates that the FDA has established that serious risks are associated with the drug. For manufacturers, black box warnings equate to decreased sales as consumers switch to other medications where possible. Not surprisingly, both of the manufacturers in this situation are reporting that a black box warning is not needed.
