The following is the summary of “Boxed Warnings and Off-Label Use of Allergy Medications: Risks, Benefits, and Shared Decision Making” published in the December 2022 issue of Allergy and Clinical Immunology: In Practice by Greiwe, et al.

The Food and Drug Administration’s job is to decide whether or not a medicine is safe and effective for human use. Even though a drug goes through a strict evaluation procedure before it hits the market, new information about the drug’s safety may emerge during clinical trials or from post-market research and observations. The boxed warning is the strongest warning the FDA may attach to prescription medicine. 

Black Box Warnings are so named because they feature prominently in the package insert, usually in the form of a thick black box, drawing the attention of both doctors and patients. As of now, more than 400 drugs carry boxed warnings, and the information addressing important hazards connected with a particular drug may, correctly or wrongly, affect patient and practitioner decision-making. When deciding whether or not to provide drugs with these warnings, healthcare providers should utilize the best available evidence and their clinical judgment. 

The “off-label” use of a licensed medication refers to the practice of administering or prescribing the medication for a purpose other than the one for which it was originally approved. Prescribers have a responsibility to inform patients of the best available evidence regarding benefits and risks so that they can engage in shared decision-making with their patients, mainly because all treatments have the risk of adverse effects.