FDA Panel Recommends Increased Codeine Regulation

A U.S. Food and Drug Administration panel of experts recommended stricter regulations for prescription drugs containing codeine, especially those used in children. The panel also recommended removing codeine from its over-the-counter monograph — an FDA guide for labeling and marketing a drug’s active ingredients — for treating coughs in children.

The recommendations came after the panel met in December 2015, eight months after the European Medicines Agency recommended against using codeine in children 12 and younger or children 12–18 years old with a history of breathing problems.

“It’s a settled issue,” Dr. Randy Flick, a professor of pediatrics at the Mayo Clinic, told MedPage Today. “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.”

Codeine is a prescription opioid painkiller that is approved to treat mild to moderate pain, often in combination with acetaminophen in drugs like Capital & Codeine and Tylenol with Codeine. Codeine also treats symptoms of cough and is in drugs like Cheracol, Cheratussin, Nalex AC and Robitussin AC.

Combination codeine and acetaminophen products are approved to treat pain in children ages two and older, but they are rarely used today. The American Academy of Pediatrics has condemned treating children with codeine since 1997, according to media reports.

Codeine is a Schedule II narcotic, meaning it has a high potential for abuse and addiction, but the FDA panel was more worried about children suffering dangerous side effects than children becoming addicted.

The FDA has been updating codeine’s warnings for almost a decade.

  • In 2007, the agency added a statement about a risk of respiratory depression in infants and nursing mothers to the label of drugs containing codeine.
  • In 2012, the agency announced it had received reports of children dying after taking codeine following a tonsillectomy (a surgery to remove the tonsils) or an adenoidectomy (a surgery to remove tissue behind nasal passages).
  • In 2013, the agency issued a black-box warning, its strongest warning, about the risk of death in children who receive codeine after a tonsillectomy or adenoidectomy.

The FDA will review the panel’s recommendations and then announce any official changes made to the drug’s approval status and or label.

Experts Overwhelmingly Vote to Increase Regulation

The FDA panel of 29 experts consisted of members of the Pulmonary-Allergy Drugs and Drug Safety and Risk Management Advisory Committees.

The panel voted in overwhelming majority on three issues:

  • The panel voted 28-1 in favor of not using codeine for pain management in children.
  • The panel voted 27-2 in favor of not using codeine to treat coughs in children.
  • The panel voted 28-0, with one abstention, in favor of removing codeine from the over-the-counter monograph.

“At this point, I don’t understand in anyway how a narcotic-based compound can be an over-the-counter drug,” Dr. Raeford Brown, a professor of pediatrics at the University of Kentucky, told MedPage Today. “It boggles my mind.”

The votes to contraindicate codeine would not affect the use of other opioids like oxycodone or hydrocodone in children.

While speaking at the panel meeting in December, Dr. Connie Houck, chair of the AAP surgical advisory panel, advised: “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.”

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