FDA Commissioner Scott Gottlieb, who has made battling the opioid epidemic a top priority, said in a statement Thursday that it is critical "to protect children from unnecessary exposure" to prescription cough medicines containing codeine or hydrocodone.
The new warnings are consistent with the labels on other drug products with opioids, including painkillers.
The FDA said it conducted extensive reviews of available data and sought expert advice on opioid use in the treatment of childhood pain and cough.More news: Blackhawks Rout Senators, 8-2
Products covered by Thursday's announcement included four with codeine, in combination with other agents such as chorpheniramine and promethazine, and five with hydrocodone along with other ingredients. "If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine", it said.
Gottlieb added that the FDA is taking steps to assure parents that treating the common cold or cough is possible without prescription opioid medicine.
Some codeine cough medicines are available over the counter in a few states, FDA noted, saying it is also considering regulatory action for these products.More news: Fossils show butterflies appeared on Earth before flowers
Then, last year, the agency warned that the opioids codeine and tramadol could cause life-threatening breathing problems in children and strengthened drug labeling to restrict their use in children younger than 12.
"It's commendable that the FDA is acting to expand safety use labeling not only for children and teens, but adults as well", said Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City.
The F-D-A says it is revising warnings on such products, and will label them for use *only* in adults over age 18.More news: Pilots Still Struggle to Land Planes at SFO
The affected products are sold by certain generic drug makers. The FDA held a risk-association discussion with its Pediatric Advisory Committee, during which experts indicated that cough due to colds or upper respiratory infections generally did not require treatment, and that the risks of prescription opioid cough therapy use did not outweigh its potential benefits.