"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", FDA commissioner Scott Gottlieb said in a statement.
Gottlieb also cited the ongoing epidemic of opioid addiction, and stressed the importance of reducing exposure to addictive drugs at a young age.
The safety labeling changes will require that the medicines have labels that no longer indicate that such drugs are appropriate for anyone under the age of 18.More news: Eli Lilly and Co (LLY) Shares Sold by Private Capital Advisors Inc
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.
The most commonly experienced side effects by patients using either of these drugs are sleepiness, nausea, vomiting, labored breathing, and others. 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. After a 2013 warning by the FDA not to give children codeine after tonsillectomy or adenoidectomy procedures, an American Academy of Pediatrics report in November 2017 found that about 5 percent of children were still being prescribed the drug. 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. And while they say some kids' cough require treatment, symptoms usually subside on their own. They must now indicate that the products no longer can be used to treat children because the risks outweigh the potential benefits.
One physician who's dealt with the aftermath of opioid overuse applauded the move.More news: Wedbush Securities Inc. Has $6.86 Million Stake in Verizon Communications Inc. (VZ)
So what's the advice for parents who may be using these medicines for their child already? Parents of children 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. According to the FDA, they should talk to their child's doctor about alternative therapies.
The FDA also held an expert roundtable and convened a meeting of its Pediatric Advisory Committee to look at all the risks associated with the use of codeine- or a hydrocodone-containing cough and cold products in children and adolescents younger than 18-years-old. Always read the labels on prescription bottles.More news: Fortnite Battle Royale Map Getting Revamped Next Week