In the latest step taken by the US Food and Drug Administration (FDA) to address the nation's opioid abuse epidemic, the agency has changed the indication of cough medicines containing opioids to exclude all pediatric patients.
Following the latest safety labeling changes, opioid cough and cold medicines containing codeine or hydrocodone are only indicated to treat coughs in adults aged 18 years or over. According to the FDA, the serious risks of these medicines are considered greater than the potential benefits to pediatric patients.
FDA Commissioner Scott Gottlieb, MD, explained any exposure to opioid drugs could lead to addiction in the future, adding the risk to this "vulnerable" section of the population could no longer be justified. "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," he stated.
Codeine and hydrocodone are often combined with other medicines - such as antihistamines, expectorants, and decongestants - in many cough, cold, and allergy medications. Examples include Hydromet (hydrocodone, homatropine) and Cheratussin Ac (codeine, guaifenesin). In many cases, over-the-counter and prescription alternatives without opioids are also available, such as Dextromethorphan or Tessalon Perles (benzonatate).
The agency has been examining the benefits and risks of opioid use in children for a number of years. In 2015, it announced an investigation into the potential risks of using medicine containing codeine to treat coughs and colds in children under 18 years of age. Last year, the FDA warned parents not to give medication containing the opioids codeine or tramadol to children due to the risk it could cause serious breathing problems.
The new regulation changes will bring labeling of opioid cough and cold medication in line with the existing labeling of other opioid products, opioid agonist and other drug combinations and other opioid analgesics. However, the FDA noted that in some states, it is still possible to purchase over-the-counter products containing codeine, warning parents to check the labels to ensure medication is indicated for use treating young children.