BALTIMORE (WJZ) — The U.S. Food and Drug Administration will now require safety labeling changes to limit the use of prescription opioid cough and cold medicines.
These requirements made on Thursday pertain to medicines containing codeine or hydrocodone in children younger than 18-years-old. After the safety labeling changes are made, the products will no longer be indicated for use to treat coughs in any pediatric population. Instead, they will be labeled for use only in adults aged 18 and older.
“It should have been done decades ago,” says Dr. Scott Krugman of Medstar Franklin Square Medical Center.
Krugman is a pediatrician and says he has never prescribed codeine. The reason: “nausea, sleep apnea — which means they stop breathing — really deep sedation so you can’t wake your child up, and there have been deaths reported with codeine, so it’s really not a great drug at all,” Krugman said.
Cherokee Layson-Wolf, a professor at the University of Maryland School of Pharmacy, says “codeine is actually an opioid product, and when we use codeine for a cough, it actually acts on the brain centers that help suppress coughs.”
Labeling for these medications will also be updated with additional safety information for adults, including an expanded boxed warning. The warning will notify people the risks of misuse, abuse, addiction, overdose and death. Slowed or difficult breathing can also result from exposure to codeine or hydrocodone.
“It’s critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone. At the same time we’re taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products,” said FDA Commissioner Scott Gottlieb, M.D.
These new requirements expand pediatric restrictions put in place in 2017 when the FDA required the addition of the FDA’s strongest warning, called a contraindication, to the labeling of prescription codeine. This alerts people that codeine should not be used to treat pain or a cough in children younger than 12 years due to a specific risk of ultra-rapid metabolism in certain patients.
Krugman says the best treatment for a child who has come down with a cold and starts coughing: “home remedies like honey, humidifiers, saline drops — things like that which you can use.”