The Problem with Black Box Warnings

A short article (T Elraiyah, et al. Ann Intern Med. Published online 29 September 2015 doi:10.7326/M15-1097) explains the problem with current black box warnings and what can be done to improve them. “A black box warning (BBW) is the highest level of warning issued by the U.S. Food and Drug Administration (FDA)…These warnings are required when there is reasonable evidence of association between the drug and a significant safety concern.” Key points:

  • BBWs “have been the subject of controversy, due in part to their opaque connection to the underlying body of evidence.”
  • The authors reviewed 70 BBWs from the top 200 drugs.  “We found only 19 (27%) provided an estimate of the likelihood of harm, and only 8 (11%) reported a CI for that estimate.”
  • “Fewer than half (43%) presented the source of evidence. None described the quality (certainty of the evidence).”
  • “None provided guidance on how to communicate or act on the evidence.”

The authors state that “BBWs infrequently contain 3 elements required for evidence-based practice (estimate of effect, source and trustworthiness of evidence, and guidance on implementation).” There are some medicines that already have a well-presented BBW, including Advair-diskus.

My take: Black box warnings can generate a lot of anxiety and may adversely affect the calculation of benefit versus harm.  Improving them could be helpful for patients and doctors alike.

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