The FDA also said it is requiring manufacturers to add new safety warnings for adult use - including an expanded boxed warning, the most prominent kind - spelling out the risks of using medications with codeine and hydrocodone.
Prescription opioid cough and cold medicines that contain codeine or hydrocodone are being stripped of their indications to treat cough in kids, FDA announced Thursday (Jan. 11).
The affected products are sold by certain generic drug makers.
The label change also proceeds a pediatric restriction set previous year that required a contraindication to prescription codeine product labels.
In 2013, the FDA issued a public warning and implemented a "black box warning" - the strongest safety statement - against prescribing codeine to children for pain management after having their tonsils or adenoids surgically removed. For those children in whom cough treatment is necessary, alternative medicines are available.
"We are taking this action after conducting an extensive review and convening a panel of outside experts".
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Common adverse effects of opioid therapies include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache, according to the FDA.
"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.
Parents whose children are now 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, the FDA advised.
"The opioid epidemic has many origins, but can begin with exposure to [opioids] at young ages", he said.
It's always important to read medicine labeling, too - even if it's not obtained by prescription.
In 2015, the FDA also announced an investigation into the possible risks of using codeine-containing medicines to treat coughs and colds in children under 18.