Opioids in Children's Cough Medicine Too Risky, FDA Panel Says


The Pediatric Advisory Committee unanimously voted against using codeine and hydrocodone in pediatric cough medication.

The FDA’s Pediatric Advisory Committee this week told the agency that risks associated with using opioids in children’s cough medicine may outweigh the benefits. Previously, the panel and other advocacy groups advised that codeine-based products should not be used to treat pediatric patients under 12.

The novel recommendation is part of the FDA’s initiative to determine how opioids should be used in children’s medications, according to STAT.

The panel set out to determine the risks and benefits of cough medication containing codeine or hydrocodone in children aged 6 to 12 years and those aged 12 to 18 years. Currently, the FDA recommends against use of codeine for the younger group of patients.

With the substantial threat of the opioid epidemic, the meeting was also a way to think about the potential implications of opioid-based cough medications, according to the article.

However, a panel member questioned whether age restrictions would be effective.

“It’s not clear to me that changing the age will have the largest impact on this, because most of the misuse that we’re seeing in adolescents is actually due to diversion, and not necessarily that kids are misusing the medications that are prescribed to them,” Sharon Levy, MD, MPH assistant professor of pediatrics at Harvard Medical School and the director of the adolescent substance abuse program at Boston Children’s Hospital, told STAT.

Physician committee members also expressed concern that children prescribed the cough medications could become addicted to the drugs. While there is not substantial evidence that the drugs effectively treat cough in pediatric patients, potentially dangerous side effects exist. Since the body turns codeine into morphine at unpredictable rates, the medication could be deadly to certain patients, STAT reported.

If the FDA aligns with the panel decision, the agency may choose to recommend against the cough medication for patients up to 18 years of age.

Previously, a 2015 panel voted that children under 18 years should not be treated with codeine; however, the agency chose to only advise against codeine use among children under 12 years, according to STAT.

After reviewing data from the Adverse Event Reporting System, 21 of the 24 deaths related to opioid-induced respiratory depression occurred in children younger than 12 years.

The FDA felt that since a majority of the deaths occurred in the younger population, they should be restricted only among these individuals. The FDA noted that they wanted to ensure older children had access to the treatment as well, according to the article.

Committee members also questioned whether OTC drugs containing codeine would be subject to similar rules.

“We do think that, ultimately, whatever decision you make today with respect to what you would recommend for the prescription products will be — we will try to apply those consistent determinations to what is done with the OTC products,” said John Alexander, the FDA’s deputy director for the division of pediatric and maternal health in the Office of Drug Evaluation in the Center for Drug Evaluation and Research.

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