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FDA advisory committee recommends banning OTC codeine sold for children
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted to ban codeine-combination medication sold over-the-counter and to contraindicate the medication for children aged younger than 18 years as both a painkiller and as cough medicine.
Further, the majority of the voters expressed a desire to ban the medication for all age groups.
“I don’t understand, in any way, how a narcotic-based compound can be an over-the-counter drug. It boggles my mind,” Raeford E. Brown Jr., MD, FAAP, professor at the University of Kentucky Medical Center, said at the committee meeting. “This gives an opportunity for parents to give 2-year-olds doses of a drug that are absolutely unregulated by anyone. The worst possible thing we can do is not put the directions for dosing on the bottles of it, leave it on the market and expect that parents are not going to use it. Parents will use it. Parents will use it every single day.”
Committee members voted to contraindicate codeine-combination medication as a pain killer for children aged younger than 18 years, then voted to contraindicate the medication as cough medicine for the same age group. In the final vote, committee members voted to ban the medication sold over the counter for the same group.
“When we talk about the use of codeine for cough, I don’t believe that there’s actually any data to support efficacy whatsoever,” Mitchell H. Grayson, MD, associate professor at the Medical College of Wisconsin, said. “There’s clearly a risk of unknown delivery of morphine with people using this drug. We don’t know what’s actually going to happen to them, so there’s clearly a risk with essentially no benefit. The more recent studies have shown that placebo is just as effective. I see no reason why this should be available for anybody as an over-the-counter drug.”
The FDA found that there are rare, but serious risks associated with codeine. In patients aged younger than 18 years who used codeine-containing products, the FDA identified 64 serious cases of respiratory depression from 1965 to 2015. These cases included 24 deaths, 21 hospitalizations, and 16 life-threatening cases. Of the 24 deaths, 21 were of children aged younger than 12 years, and nine of the 21 deaths occurred when using codeine for a tonsillectomy or adenoidectomy.
Further, between 2004 and 2013 in 63 hospitals, the FDA found 73 ED visits for codeine cough medication products and 261 ED visits for codeine pain killer products. Accidental or unintentional ingestion and allergic reaction accounted for the majority of these visits.
“We have a huge epidemic: a prescription drug problem,” Michelle Harkins, MD, associate professor at the University of New Mexico, said during the meeting. “Having something sit behind a counter that anybody can get access to as a starting narcotic seems crazy. It seems like we need to do something to combat our prescription drug abuse potential.”
The FDA is not required to follow the advice of its advisory committees, but it normally does. – by Will Offit
Reference:
Food and Drug Administration, Pulmonary-Allergy Drugs Advisory Committee. Clinical briefing document. December 10, 2015.