FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or hard breathing to the Boxed Warning, the most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.
The FDA on Thursday said it will require a safety label change for cough and cold treatments containing codeine or hydrocodone to indicate these medications are no longer safe for use in children.
Gottlieb also cited the ongoing epidemic of opioid addiction, and stressed the importance of reducing exposure to addictive drugs at a young age. These medicines carry serious risks, including slowed or hard breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children.
According to the FDA, labeling for adult-only use of prescription opioid cough and cold medicines that contain codeine or hydrocodone will also now include updated safety information.
It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment. Past year the restrictions were expanded to include safety labels that carried the contraindication warning, the FDA's most severe warning, to say that it should not be used for patients under the age of 12. That labeling restricted use to children aged 12 and over "due to a specific risk of ultra-rapid metabolism in certain patients", the FDA explained.
The new warning follows an extensive FDA review of data and a meeting of the agency's Pediatric Advisory Committee in September.
In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said.
Common side effects of opioids include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache.
FDA's strongest warning, called a Contraindication, to the drug labels of codeine and tramadol alerting that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years.
"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 agency urged parents to read the labels on prescription bottles.
These new actions further limit the use of these medicines beyond the 2013 FDA restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.
So what's the advice for parents who may be using these medicines for their child already?