FDA Panel Urges Stronger Regulation of Codeine
Written by Editor   
Wednesday, January 13, 2016 12:00 AM

The FDA is moving towards tighter restrictions on codeine in OTC medications, especially for children.


An FDA advisory panel wants more restrictions on codeine use in children, and it said the FDA should move now to remove codeine from the over-the-counter monograph for use in the treatment of cough for children.

Members of the Pulmonary-Allergy Drugs (PADC) and Drug Safety and Risk Management Advisory Committees voted 28-1 in favor of expanding the contraindication for codeine to include any pain management for children. More specifically, nearly three-quarters of panelists favored a contraindication for individuals under 18-years-old; others recommended a lower threshold.

The panel also voted 26-3 in favor of including a new contraindication for codeine for the treatment of cough. (One vote was miscast, making the actual tally 27-2.) Once again, nearly three-quarters supported the strongest category of contraindication which would exclude those under 18-years-old.  In its third vote, the panel voted 28-0 in favor of removing codeine from the over-the-counter monograph, with one abstention.

Codeine sulfate is available as a single agent, but is frequently combined with acetaminophen to treat "mild to moderately severe pain," according to the FDA's briefing documents. Single-ingredient codeine has not been approved for children under age 18. However, combination codeine-acetaminophen products are available for use by children as young as 2-years-old.

Codeine is also used to soothe coughing and is an ingredient in some prescription products for cough, cold, and upper respiratory allergies. The use of codeine in children has been questioned over the last 10 years following reports of deaths mainly relating to respiratory depression.

Associate professor of anesthesiology and pediatrics at the Mayo Clinic in Rochester, Minn, supported the strongest possible restrictions, as well as removal of codeine from the agency's monograph. He said those practicing pediatric pain medicine haven't used it for 20 years. "It's a settled issue."

"At this point, I don't understand in anyway how a narcotic-based compound can be an over -the-counter drug. It boggles my mind,” said another.

"Because of its variability in metabolism, the increased risk of adverse effects in children and the lack of data showing efficacy for treating cough in children, the use of codeine or any other opioid cannot be recommended for the treatment of cough in children. Likewise, for acute and postoperative pain in children, alternative strategies should be recommended, including other opioids,” said another.


Source:  http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/55159