Tag Archives: Black box warning

NPR: Safety Problems in 1/3rd of New Medications

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From NPR: Safety Problems in 1/3rd of New Medications After FDA Approval

From 2001-2010:

Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a “black box” warning on side effects or warranted a safety announcement about new risks to the public, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine and colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28…

It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted “accelerated approval” and drugs that were approved near the regulatory deadline for approval…

“In the 21st Century Cures Act, there’s a push to have the FDA move to further support the use of surrogate markers … [but] they’re more likely to have concerns in the post-market setting.”…

The study included market withdrawals of three drugs: The anti-inflammatory drug Bextra; a drug called Zelnorm that was used to treat irritable bowel syndrome; and the psoriasis drug Raptiva. Bextra and Zelnorm were withdrawn over cardiovascular risk, and Raptiva was withdrawn because of increased risk of a rare and fatal infection that causes brain damage.

My take: FDA approval does not guarantee safety.  All medications have potential risks along with their benefits.

 

The Problem with Black Box Warnings

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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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