Black Box Warnings

The U.S. Food and Drug Administration (FDA) requires black box warnings (boxed warnings) for medications that may pose serious safety risks. These warnings include information about rare, dangerous side effects and important instructions about the safe use of the medication. Warnings are located inside a black border and are printed in bold font. These warnings are the most serious type of medication warning issued by the FDA.

Black box warnings are intended for physician use to help them determine if the benefits of a medication outweigh the risks. They are usually located either on the insert that comes inside the medication packaging, on the FDA’s website or on the manufacturing pharmaceutical company’s website.

Health care professionals are required to provide information to individuals about the risks of taking a medication that contains a black box warning. Although many of the risks are rare, the benefits and risks of these medications should be discussed prior to usage. Certain medications with a black box warning may be administered in supervised settings or may require additional training for a health care professional prior to administration. A pharmacist can also be consulted about black box warnings to help address any questions.

The FDA analyzes safety concerns of medications when reports are submitted by consumers or health care professionals. If the FDA identifies a serious concern linked to a certain medication, the pharmaceutical company may be required to add a black box label to that medication. Serious concerns include reactions that may result in permanent disability or death.