FDA committee to evaluate use of opioid cough medicines in children: 3 things to know

The Food and Drug Administration's Pediatric Advisory Committee will convene in September to evaluate the use of prescription cough medications containing opioids in the treatment of pediatric patients.

Here are three things to know.

1. The move to convene the advisory committee comes after the FDA issued a drug safety communication in April, restricting the use of codeine and tramadol when treating pain and cough in children under 12 years old. Tramadol is approved to treat pain, and codeine is approved for the treatment of cough and pain. The FDA also recommended against prescribing these medications to breast feeding mothers due to possible harm to infants.

2. The FDA's panel of independent experts will convene Sept. 11 and Sept. 12 in Washington, D.C., to assess the use of prescription drugs containing codeine and hydrocodone for the treatment of cough in pediatric patients.

"There's perhaps no more important mandate that we have at the FDA than safeguarding the health and safety of children," said Scott Gottlieb, MD, commissioner of the FDA. "For that reason, I believe it's important that parents and healthcare providers have the best information available to inform the decisions they make about a child's health. 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."

3. Dr. Gottlieb has made the nation's opioid crisis a top priority for the FDA since taking the helm of the regulatory agency in May. Under his leadership, the federal agency has proposed new opioid prescribing rulesfor providers and issued a withdrawal request to Endo International to remove its opioid painkiller Opana ER from the market, marking the first time the FDA issued such a request for an opioid due to public health concerns. Endo issued a voluntary recall of the product in July.

More articles on opioids: 
Insys settles Illinois opioid lawsuit for $4.45M 
Price praises China for help with opioid crisis 
Express Scripts to limit opioids for first time users: 4 things to know

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