A black box warning occurs when the FDA determines that a medication carries a serious risk of a severe adverse reaction. When this occurs, a heavy black box is placed around the specific warning in literature produced by the pharmaceutical company that manufactures the specific medication. Included in the black box (literally a dark black line drawn around the warning) are often recommendations for increased monitoring when a person is on these medications, which might include more frequent visits, lab work, and other studies.
Examples of black box warnings that might pertain to medications prescribed for bipolar disorder include:
• Lithium toxicity, and the need to be able to monitor lithium levels in the body.
• Increased risk of suicidal thoughts and behaviors with antidepressants in children and adolescents.
• An increased risk of death in elderly patients with dementia who are taking atypical antipsychotic medications.