SILVER SPRING, Md. -- 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 for use in the treatment of cough for children -- or said, some panelists, for anyone.
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. an associate professor in the department of Orthopaedic surgery at the University of Texas Southwestern Medical Center in Dallas, said the question was "outside her wheelhouse."
Ubiquitous Codeine
Codeine sulfate is available as a single agent, but is frequently combined with acetaminophen to treat "mild to moderately severe pain," . 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.
The FDA comes late to the effort to restrict codeine -- regulatory agencies in Europe, Canada, and Australia have already enacted tighter controls.
Always a Better Choice
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."
Flick continued, "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."
The orthopedic surgeon Finnegan was the lone dissenter on the first vote. But far from recommending "no change" to the current contraindication. She said she had "no problem" with recommending against use of codeine for any pain management, but did not support a full contraindication. The current contraindication, which was added in 2013, states: "Codeine sulfate is contraindicated for postoperative pain management in children who have undergone tonsillectomy relates or adenoidectomy."
A patient representative from Mount Pleasant, Mich., urged the committee to reconsider broad restrictions on codeine use, noting that codeine alternatives such as morphine were too difficult to access. A better alternative, she said, would be limiting the contraindication language to children younger than 6. "A physician will not prescribe you with morphine if they're not familiar with you." Nelson added that her child would not have gotten any pain relief from her sickle-cell anemia without codeine.
, an associate professor of internal medicine and pediatrics at Vanderbilt University, supported broader contraindications for both pain and cough. Concerning codeine's use as a cough suppressant, she argued, "Cough is a self-limiting illness and the potential for harm is greater than the illness."
In regard to the third matter, whether to exclude codeine from the monograph for use in the treatment of cough for children, professor of anesthesiology and pediatrics at the University of Kentucky wholeheartedly supported removal.
"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." Brown called the option of removing drug from the monograph below a certain age by simply omitting dosing instructions "the worst possible thing we can do." He continued "This gives an opportunity for parents to give two-years-olds doses of drug that are absolutely unregulated by anyone."
Among those testifying was chair of the surgical advisory panel for American Academy of Pediatrics (AAP) and a senior associate in perioperative anesthesia at Boston's Children's Hospital, who noted the AAP, during the public portion of hearing, that the AAP recommends codeine be contraindicated for cough and pain in all children, as well as removed from the over-the counter monograph for the treatment of cough.
"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," Houck said.