A federal committee will meet in three weeks to consider whether cough medicine containing certain opioids should be prescribed to children, the Food and Drug Administration announced Monday.

The agency already warned in April that drugs containing codeine, which is an opiate, “should not be used to treat pain or cough” in children under 12. The warning must appear on those drugs’ labels. At the time, the agency said that codeine, along with tramadol, an opioid found in some pain medications for children, “carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years.”

The upcoming Sept. 11 meeting of the agency’s Pediatric Advisory Committee will consider medicines containing codeine, as well as medicines containing hydrocodone, an opioid derived from codeine.


FDA Commissioner Scott Gottlieb has made it a priority of his agency to reduce opioid abuse. This upcoming meeting “will focus on the use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients, including current treatment practices and benefit-risk considerations,” Gottlieb said in a statement.

An FDA spokesperson declined to provide more information about specifically what the committee will discuss, but said that discussion questions will be made available online before the meeting.

In advance of the September meeting, the FDA held an “expert roundtable” attended by representatives of health organizations like the American Academy of Pediatrics. The participants agreed that it is not appropriate to give opioids to children to treat their cough, according to an FDA summary of the meeting.

Leave a Comment

Please enter your name.
Please enter a comment.

  • I hope the committee realizes that children need relief from severe pain and from unrelenting cough. As a surgeon, the judicious use of hydrocodone for postoperative pain and pain related to certain acute infections is necessary for the comfort of the patient. Rarely do I prescribe hydrocodone for cough, but sometimes a cough can prevent a child (and their parents) from sleeping at night. Please don’t make recommendations that will handcuff those of us who prescribe narcotics in the best interest of our patients.

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy