Recently, a US Food and Drug Administration advisory panel has asked for stricter restrictions on codeine in regards to its prescription to children. As a matter of fact, the FDA has recommended that the drug no longer be sold as on over-the-counter medicine for treating cough in children. Some panelists even argued that the drug should not be sold to treat the cough of anyone, no matter the age.
The FDA classifies Codeine sulfate as a single agent, but it is often combined with the analgesic acetaminophen for the treatment of “mild to moderately severe pain.” The latter is sometimes prescribed to children with a persistent cough—in children as young as two years old—but the single-agent codeine has not been approved to treat children under the age of 18 for any reason.
The advisory panel actually consisted of members from both the Drug Safety and Risk Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee. Overall they voted 28-1 in favor of contraindication expansion for codeine so that it will include pain management for children. In particular, roughly 75 percent of the panel favored codeine contraindications for those under the age of 18 while others recommended a lower age threshold.
In addition, this same collective panel also voted 26-3 in favor of the new codeine contraindication inclusion of treatment for cough. And, as before, roughly 75 percent of the panel supported contraindications in the strongest category, which excludes minor patients (those under the age of 18).
And a third vote found the panel in 28-0 favor of removing codeine from the over-the-counter monograph. One voter, University of Texas Southwestern Medical Center associate professor of Orthopaedic surgery abstained, saying the question was “outside her wheelhouse.”
Constance Houck, MD is a chair for the surgical advisory panel of the American Academy of Pediatrics as well as a senior associate in perioperative anesthesia with Boston’s Children Hospital.
She testified: “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.”
