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In the United Statesmarker, a black box warning (also sometimes called a black label warning or boxed warning) is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning.

A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effect. The U.S. Food and Drug Administration (FDA) can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires.

Examples

Black box warnings on drugs have received increased media attention in the United States since 2004. Among some of the more widely covered stories:
  • The FDA has required that black box warnings be placed on all antidepressant medications warning they may result in increased risk of suicidal tendencies in children and adolescents.
  • FDA advisors have recommended that Pfizer be required to place a black box warning on their NSAID celecoxib (U.S. trade name Celebrex).
  • As of 17 November 2004, the FDA has required a black box warning on the Depo-Provera contraceptive injection, due to the risk of significant loss of bone density with long-term use.
  • As of October 9, 2006, the FDA added a black box warning to the anticoagulant warfarin due to the risk of bleeding to death.
  • In February 2006, the FDA's Drug Safety and Risk Management Advisory Committee voted to include black box warnings on methylphenidate formulations used to treat ADHD, such as Ritalin, due to possible cardiovascular side-effects. A month later, the agency's Pediatric Advisory Committee effectively rejected recommending boxed warnings for both cardiovascular and psychiatric adverse effects. Minutes and transcripts of the relevant meetings are available on the FDA website.
  • On November 14 2007, the FDA added a black box warning to the diabetes medication Avandia, citing the risk of heart failure or heart attack to patients with underlying heart disease, or are at a high heart attack risk.
  • On July 8 2008, the FDA ordered a black box warning on certain antibiotic medications containing fluoroquinolone, which has been linked to tendon ruptures and tendinitis. Included were the popular drugs Cipro, Levaquin, Avelox, Noroxin and Floxin.


References

  1. http://www.nimh.nih.gov/health/topics/child-and-adolescent-mental-health/antidepressant-medications-for-children-and-adolescents-information-for-parents-and-caregivers.shtml
  2. Pediatric Advisory Committee documentation available at:
  3. Drug Safety and Risk Management documentation available at:


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