FDA boxed warnings: how to prescribe drugs safely.
Boxed warnings, commonly referred to as "black box" warnings, are issued by the U.S. Food and Drug Administration and featured in the labeling of drugs associated with serious adverse reactions. These safety concerns are typically identified through the Adverse Event Reporting System and the Office of Surveillance and Epidemiology, which evaluates postmarket safety findings. The most common type of warning is issued when there is a potentially serious adverse effect that must be carefully weighed against the potential benefit of the drug. Warnings are also issued to draw attention to dosing, monitoring requirements, and potential drug interactions. Boxed warnings have been issued recently for oral sodium phosphate bowel preparations, fluoroquinolone antibiotics, and salmeterol. Despite these highly publicized warnings, all of these medications remain viable treatment options with appropriate patient selection. Ultimately, physicians must decide whether to prescribe drugs with boxed warnings.
O'Connor
Nina R
NR
Chestnut Hill Family Practice Residency Program, Chestnut Hill Hospital, 8815 Germantown Ave., Philadelphia, PA 19118, USA. nina_o'connor@chs.net
D000420:Albuterol / Q000009:adverse effects / Q000031:analogs & derivatives; D000900:Anti-Bacterial Agents / Q000009:adverse effects; D001993:Bronchodilator Agents / Q000009:adverse effects; D017277:Drug Approval; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D024841:Fluoroquinolones / Q000009:adverse effects; D006801:Humans; D010710:Phosphates / Q000009:adverse effects; D055553:Prescription Drugs / Q000009:adverse effects; D000068299:Salmeterol Xinafoate; D014481:United States; D014486:United States Food and Drug Administration
D000900:Anti-Bacterial Agents; D001993:Bronchodilator Agents; D024841:Fluoroquinolones; D010710:Phosphates; D055553:Prescription Drugs; D000068299:Salmeterol Xinafoate; D000420:Albuterol; C018279:sodium phosphate