FDA Releases New Requirements For Prescription Opioid Cough And Cold Medicines

FDA changes label safety requirements on prescription opioid, cough medicines

Prescription opioid cough and cold medicines: Drug Safety Communication - FDA requires labeling changes.

The agency said it is requiring manufacturers to change the wording on their labels to make clear that such products should not be used for anyone younger than 18.

New safety labeling requirements about who should take prescription opioid cough and cold medicines with codeine or hydrocodone are due to roll out following a United States Food and Drug Administration announcement.

Not only will these medications get new safety labeling about the age of users, they will also get new labels about safe use in general, said the FDA. "At the same time we're taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products", said FDA Commissioner Scott Gottlieb, M.D.

According to the announcement, labeling for those medications is also being updated with additional safety warning for adult use notifying users about the risks of misuse, abuse, addiction, overdose, and death, along with slowed or hard breathing.


Gottlieb also cited the ongoing epidemic of opioid addiction, and stressed the importance of reducing exposure to addictive drugs at a young age. 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.

In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said. They must now indicate that the products no longer can be used to treat children because the risks outweigh the potential benefits. Experts indicated that although some paediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment.

The most commonly experienced side effects by patients using either of these drugs are sleepiness, nausea, vomiting, labored breathing, and others.

"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. For those children in whom cough treatment is necessary, alternative medicines are available. "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. Caregivers should also read labels on non-prescription cough and cold products.

In September, the FDA met with the Pediatric Advisory Committee to determine the dangers associated with using opioids in children's cough medicine.

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