Prescription cough and cold medicines containing opioids will no longer be indicated for use to treat cough in children younger than 18 because of serious risks that “outweigh their potential benefits with this population,” the Food and Drug Administration (FDA) announced in a News Release.
The agency said it was also adding new safety information for adult use to the drugs’ labels and expanding the Boxed Warning on the products to include additional safety information regarding the risk of misuse, abuse, addiction, overdose and death, as well as slowed or difficult breathing that can result from exposure to these products. The ruling applies to prescription cough and cold medicines that contain codeine or hydrocodone, an opioid painkiller.
“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction. It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population,” FDA Commissioner Scott Gottlieb, MD, said. “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.”
The FDA made the decision to make changes to the prescribing of opioid-containing cough and cold medicines after a comprehensive assessment of the risks and benefits of these medicines. The new requirements regarding younger patients expand pediatric restrictions put in place last year when the FDA required the addition of the FDA’s strongest warning, called a contraindication, to the labeling of prescription codeine products alerting that codeine should not be used to treat pain or cough in children younger than 12 years due to a specific risk of ultra-rapid metabolism in certain patients. It was the opinion of the FDA’s Pediatric Advisory Committee and an expert roundtable that the restrictions should be expanded to include children younger than 18 years of age.
“Today’s action is one example of the FDA’s work to further protect patients for whom the risks of opioid products outweigh the benefits,” the FDA News Release stated.
Source: FDA News Release