FDA
18th December 2015

Joint Advisory Committee Votes to Restrict the Use of Codeine Among Children

Last week, the FDA held a joint meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) to address the safety of codeine in children 18 years and younger.

Joint Advisory Committee Votes to Restrict the Use of Codeine Among Children

Last week, the FDA held a joint meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) to address the safety of codeine in children 18 years and younger.

The panel voted 28-1 in favor of expanding the contraindication for codeine to encompass any pain management for children. For the second vote, the panel voted 27-2 in favor of adding a new contraindication for codeine in the treatment of cough. The final vote resulted in 28 yes’, 0 no’s, and 1 abstention in favor of removing codeine from the OTC monograph.During the committee meeting, Randy Flick, MD, MPH, associate professor of anesthesiology and pediatrics at the Mayo Clinic in Rochester, Minn, voiced his support of strong restrictions, in addition to the removal of codeine from the current monograph. “For every indication that we are talking about here there is a better alternative…When we balance the risk and benefit of codeine in the setting of available alternatives it simply doesn’t make sense,” stated Flick.

While single-ingredient codeine is not approved for children under 18 years, combination codeine-acetaminophen products are available for use in children 2 years and older. Codeine is used to treat mild to moderately severe pain, as well as to soothe coughing. However, over the past decade, the use of codeine in pediatrics has become an increasing concern due to reports of death related to respiratory depression. Importantly, regulatory agencies in Europe, Canada and Australia have already strengthened codeine controls.

The agency is not obligated to follow its panel’s recommendation, but normally does so.

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