Dentists Heeded FDA Warning on Codeine

Dentists Heeded FDA Warning on Codeine 1024 683 Mary Bates, PhD
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An FDA black box warning directed at ENT doctors performing tonsil and adenoid surgeries also affected prescribing patterns by dentists.

Codeine, an opioid analgesic, was popular in pediatrics because it was thought to be a safe alternative to morphine. However, in recent years, the drug has been found to have variability in therapeutic doses, with the toxic dose depending on patient-specific genetic variations. Some patients are ultra-rapid metabolizers of codeine and thus may experience increased risk of death from codeine consumption.

Following the report of deaths associated with codeine among children who were shown to be ultra-rapid metabolizers, the U.S. Food and Drug Administration (FDA) began an investigation into the drug. In 2013, the FDA issued a black box warning that advised health care providers to use alternative analgesics following tonsillectomy or adenoidectomy and avoid codeine in these patients. By the end of these investigations in 2017, the FDA recommended against the use of codeine in all settings.

“Those early FDA warnings were very much focused on ear, nose and throat doctors who were doing tonsil and adenoid surgeries,” says Janice Townsend, DDS, MS, chief of Pediatric Dentistry at Nationwide Children’s. “The FDA did not make recommendations to other professionals regarding codeine until 2017.

“We wanted to find out if dentists as a profession were paying attention and responding to these early warnings even though they were not specifically focused on dentistry.”

To answer this question, Dr. Townsend collaborated with Yuri Sebastião, PhD, MPH and Jennifer Cooper, PhD, of Nationwide Children’s Center for Surgical Outcomes Research. They evaluated the change in rates of codeine and alternate opioid prescription filing after dental procedures among children from before to after the 2013 FDA black box warning against codeine use for pediatric tonsillectomy and adenoidectomy.

The researchers conducted a retrospective study using Ohio Medicaid claims data gathered between August 2011 and August 2016. The results were published in the journal Pediatric Dentistry. The research was supported by a grant from the National Institutes of Health lead by Deena Chisolm, PhD, director of the Center for Innovation in Pediatric Practice and Katherine Deans, MD, director of the Center for Surgical Outcomes Research.

The study found that the 2013 FDA black box warning against codeine prescription after tonsillectomy and adenoidectomy was associated with an immediate 0.4% reduction in codeine prescription fill rates after pediatric dental procedures in Ohio. There was no such association with alternative opioid prescription filing.

Dr. Townsend says that although overall opioid prescriptions did decrease during the period of the study, there was a significant, sharp drop in codeine that stood out.

“In general, dentists are prescribing fewer opioids for children than we used to,” says Dr. Townsend, who is also the chair of the Division of Pediatric Dentistry at The Ohio State University College of Dentistry. “And this reduction was especially significant for codeine during the time of this investigation.”

The reduction in codeine prescribing appears to be in part an effect of the FDA black box warning, even though the warning was primarily intended for surgeons following tonsillectomy and adenoidectomy. This study is unique in that it shows a significant change in a group of health care providers who were not targeted in the guideline change.

“This shows that the dental community is attuned to what the broader medical community is doing,” says Dr. Townsend. “Even if the FDA isn’t directing its messages to us, we’re still taking that information and integrating it into our practices.”



Townsend JA, Sebastião YV, and Cooper JN. Effect of FDA warning on codeine and alternate opioid prescribing after pediatric dental procedures in Ohio. Pediatric Dentistry. 2019; 41(6): 439-445.

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About the author

Mary a freelance science writer and blogger based in Boston. Her favorite topics include biology, psychology, neuroscience, ecology, and animal behavior. She has a BA in Biology-Psychology with a minor in English from Skidmore College in Saratoga Springs, NY, and a PhD from Brown University, where she researched bat echolocation and bullfrog chorusing.