A black box warning is a notice on the packaging of a prescription drug which warns patients and prescribers that the drug has potentially dangerous side effects. This warning system is primarily used by the Food and Drug Administration (FDA), an American regulatory agency which oversees the safety of pharmaceuticals produced and sold in the United States. Other national regulatory agencies may use different systems to indicate that drugs are potentially dangerous.
When Does the FDA Require a Boxed Warning?
The FDA requires a black box warning for one of the following situations:
- The medication can cause serious undesirable effects (such as a fatal, life-threatening or permanently disabling adverse reaction) compared to the potential benefit from the drug. Depending on your health condition, you and your doctor would need to decide if the potential benefit of taking the drug is worth the risk.
- A serious adverse reaction can be prevented, reduced in frequency, or reduced in severity by proper use of the drug. For example, a medication may be safe to use in adults, but not in children. Or, the drug may be safe to use in adult women who are not pregnant.