Data Support FDA Restrictions on Child Cough and Cold Medicines

Surveillance data showed more adverse events for children exposed to hydrocodone than codeine
Surveillance data showed more adverse events for children exposed to hydrocodone than codeine

(HealthDay News) — New research supports expanded restrictions on opioid-containing cough and cold medications (CCMs) for children, according to a short communication published recently in Clinical Toxicology.

Ian M. Paul, M.D., from the Penn State College of Medicine in Hershey, and colleagues characterized adverse events in children <12 years old associated with CCMs that include both an opioid (codeine or hydrocodone) and over-the-counter ingredient. Cases were identified from a safety surveillance program (January 2008 and December 2015).

Related Articles

The researchers found that 114 of the 7,035 cases reviewed (2 percent) involved an opioid-containing product. The adverse event was at least potentially related to the opioid ingredient in 98 cases (39 percent codeine; 61 percent hydrocodone). Three fatality cases involved CCMs with hydrocodone and an antihistamine. Somnolence, lethargy, and/or respiratory depression were more commonly reported among non-fatal hydrocodone cases versus non-fatal codeine cases (86 versus 61 percent; P =.005).

"Health care providers should never prescribe opioid-containing cough and cold products to children," Paul said in a statement. "Ever."

Abstract/Full Text (subscription or payment may be required)