FDA Cautions On Cough Meds.
SILVER SPRING, Md. -- The Food and Drug Administration announced it is requiring safety labeling changes aimed at limiting the use of prescription opioid cough and cold medicines containing codeine or hydrocodone by anyone under the age of 18.
"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," Scott Gottlieb, FDA's commissioner, said in a prepared statement. "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."
After safety labeling changes are made, these products will be labeled for use only in adults age 18 and older, the FDA said on January 11.
Labeling also is being updated with additional safety information for adult use, including an expanded Boxed Warning, FDA's most prominent warning notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.
Parents of children currently prescribed a cough and cold medicine containing codeine or hydrocodone are encouraged to talk to their child's health care professional about other treatment options, and all caregivers should read labels on nonprescription cough and cold products, the agency said.
Some products sold over the counter in a few states may contain codeine or may not be appropriate for young children, according to the FDA.
Meanwhile, results from the National Institute on Drug Abuse and the University of Michigan's annual drug abuse survey were released in December, showing that the percentage of teens using O-T-C cough medicine containing dextromethorphan (DXM) to get high remains at just 3%, the lowest level for teen cough medicine abuse since 2015 and down from 6% in 2006.
"Public policy and education are both vitally important to combating teen O-T-C cough medicine abuse," said Scott Melville, president and chief operating officer of the Consumer Healthcare Products Association, which has worked to help reduce teen DXM abuse.