Boxed warning

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In the United States, a boxed warning (sometimes 'black box warning', colloquially) is a type of warning that appears on the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text.[1] The FDA can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.[2] [3]

Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns. It is not necessarily true that a physician and patient will have a conversation about a drug's boxed warning after it is issued.[4] For instance, an FDA-mandated boxed warning decreased rosiglitazone use by 70%, but that still meant 3.8 million people were given the drug. Later research indicated that after receiving an FDA advisory, there was a decrease in rosiglitazone use, due to a combined effect of media exposure, advisory, and scientific publications, whereas pioglitazone (with a similar advisory) did not similarly decrease in use.[5] This challenges the idea that physicians and patients will have a conversation after a boxed warning is issued. Throughout the country, boxed warnings will be translated into prescription patterns differently by different physicians.

In 2005, the FDA issued a boxed warning regarding the risk of atypical antipsychotics being prescribed among elderly patients with dementia. This advisory was associated with a decrease in use of antipsychotics, especially in elderly patients with dementia.[6]


Boxed warnings on drugs have received increased media attention in the United States since 2004. Among some of the more widely covered stories:


  1. ^ "The heading and the summary must be contained within a box and bolded." 21CFR201.57 Subpart B (a)(4)
  2. ^ U.S. Food and Drug Administration. "Guidance for industry. Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products—content and format". Retrieved 2010-02-21. 
  3. ^ National Institute of Mental Health, Antidepressant Medications for Children and Adolescents: Information for Parents and Caregivers."
  4. ^ Shah ND, Montori VM, Krumholz HM, Tu K, Alexander GC, Jackevicius CA. Geographic Variation in the Response to FDA Boxed Warnings for Rosiglitazone. N Engl J Med. 2010;22:2081-2084. [1]
  5. ^ Cohen A, Rabbani A, Shah N, Alexander GC. Changes in glitazone use among office-based physicians in the United States, 2003-2009. Diabetes care. 2010;33:823-825. [2]
  6. ^ Dorsey R, Rabbani A, Gallagher SA, Conti R, Alexander GC. The impact of boxed warnings on the use of atypical antipsychotic medicines. Archives of Internal Medicine. 2010;170:96-103. [3]
  7. ^ "Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection". Archived from the original on 2007-08-09. Retrieved 2007-08-15. 
  8. ^ "Black Box for Warfarin". Retrieved 2007-08-15. 
  9. ^ Associated Press (February 10, 2006). "Strongest warning suggested for ADHD drugs". CNN. Retrieved 2007-08-15. 
  10. ^ "'Black Box' ADHD Drug Warning Rejected". CBS News. March 22, 2006. Retrieved 2007-08-15. 
  11. ^ Pediatric Advisory Committee documentation available at: "2006 FDA Advisory Committees Meeting Documents by Center". U.S. Food and Drug Administration. February 5, 2007. Retrieved 2007-08-15. 
  12. ^ Drug Safety and Risk Management documentation available at: "CDER 2006 Meeting Documents". U.S. Food and Drug Administration. February 1, 2007. Retrieved 2007-08-15. 
  13. ^ "Glaxo's Avandia to carry heart-attack warning". MarketWatch. November 14, 2007. Retrieved 2007-11-14. 
  14. ^ "FDA orders 'black box' label on some antibiotics". CNN. 2008-07-08. Retrieved 2008-07-08. 
  15. ^ FDA. "Public Health Advisory: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban". Retrieved 2009-07-01. 
  16. ^ "FDA Announces Addition of Boxed Warning to METACAM® (meloxicam) Labels". October 27, 2010. 
  17. ^
  18. ^ "FDA Drug Safety Communication: FDA approves label changes for antimalarial drug mefloquine hydrochloride due to risk of serious psychiatric and nerve side effects". July 29, 2013. 

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