The U.S. Food and Drug Administration (FDA,) has added strict restrictions to the use of children’s cough medicines that contain opioids, such as codeine or oxycodone.
"After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older," the FDA said in a news release.
The country is in the middle of an opioid abuse epidemic that is devastating families in just about every state. An updated Boxed Warning label will also warn adult users "about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone," the agency added.
FDA Commissioner Dr. Scott Gottlieb said the agency is concerned about exposing children to opioids unnecessarily.
“We know that any exposure to opioid drugs can lead to future addiction. 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,” Gottlieb said in the press release.
The new rules announced Thursday were "based on an extensive review of available data and expert advice," the agency said.
They go much further than the 2017 labeling rules -- restricting use of codeine-containing products to everyone under the age of 18, and including cough-and-cold products that contain a second drug, the opioid oxycodone.
In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said.
"Experts indicated that although some pediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment," the agency said. "Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits."
The press release also pointed to known side effects of opioid medications, "drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache."
The FDA recommends that parents currently using these medications for their child should speak with their child’s doctor about alternative therapies
It's always important to read medicine labeling, too -- even if it's not obtained by prescription.
"Caregivers should also read labels on non-prescription cough and cold products," the FDA said, because "some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children."
Story source: EJ Mundell, Health Day Reporter, https://www.webmd.com/drug-medication/news/20180111/fda-bans-opioid-containing-cough-meds-for-kids#1