FDA Committee to Review Safety of Hydrocodone, Codeine for Children

In its latest effort in the war against the opioid epidemic, the US Food and Drug Administration has announced an upcoming Pediatric Advisory Committee review of prescription medications containing hydrocodone or codeine that are currently approved to treat children.

“It is vital we understand the potential complications that can occur when using opioid-containing medications in children, even according to labeled instructions. This is an area that the agency is continuing to evaluate,” said FDA commissioner Scott Gottlieb in a statement.

Gottlieb acknowledged that in some cases, children’s cough and cold symptoms can be severe enough to warrant the use of cough suppressants and other prescription medications. However, these medications pose risks that can disproportionately affect children, because they may contain opioids.

“Often times [prescription opioid] medication might not be necessary at all,” Gottlieb said, citing the results of an April 2017 expert roundtable meeting, during which the American Academy of Pediatrics and the American Academy of Family Physicians suggested that other medications and non-drug therapies may be more appropriate than hydrocodone or codeine for use in children, depending on the situation.

That sentiment was echoed by Adam Litroff, DO, director of Pediatric Emergency Care at Huntington Hospital in New York.

“We're certainly aware that there are multiple types of drugs that maybe aren't quite the right choice for pediatric patients, and we do have several different options.” Litroff said in an interview with MD Magazine. “The easiest way to remedy this is certainly just to avoid using those medications to treat your patients.”

For Michael Grosso, MD, medical director and chairman of pediatrics at Huntington Hospital, the FDA’s recent step bodes well for pediatricians across the nation.

“I'm among those individuals who would see a strong FDA as an important part of a safety infrastructure for healthcare,” Grosso told MD Magazine. “The number of pharmaceuticals that enter the market is so large, and the depth of knowledge to understand their risk-benefit ratios is so daunting that I think practicing physicians need some help.”

The FDA has consistently acted on a multi-pronged effort towards curbing opioid abuse at-large and in children leading up to and following Gottlieb's appointment as commissioner in May. In April, the agency mandated changes to the labeling of prescription codeine products including a contraindication for codeine use in children younger than 12-years-old. The agency also issued tips for consumers on how to safely treat cold symptoms in children without resorting to medicines, and even continues to fund research that supports the idea that “most young children do not need medicines to treat a cough or cold.”

“All this work is essential to reducing preventable harm from opioid-containing medications and keeping children safe. We look forward to a robust discussion at the meeting this fall and will continue to share updates with the public on the steps the agency is taking to address this important issue,” Gottlieb said.