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The FDA will evaluate prescription opioid drugs used to treat cough in children

In a statement released by the FDA, it was announced that the organization will carefully evaluate the approved use of prescription opioid medications in cough medicines for children.

The FDA believes it is important to provide parents and health care providers with the best information available when making decisions about a child’s health.

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Earlier this year, the FDA met with the American Academy of Pediatrics and the American Academy of Family Physicians, to discuss the use of cough suppressants, specifically opioid cough suppressants, by children. Key takeaways from the meeting included determining the right treatment based on length and severity of symptoms, as well as treating what’s causing the symptoms.

The FDA wants to make sure health care professionals and parents are not just trying to quiet the cough, but are open to exploring other options that include non-drug treatments.

FDA to meet Sept. 11th & 12th to discuss opioid treatments for cough

The Pediatric Advisory Committee will focus on the use of prescription opioid products containing hydrocodone and codeine, for treatment of cough.

Scott Gottlieb, the FDA’s commissioner, feels it is vital to understand the potential complications that can occur during the use of opioid-containing medication treatment for children.

Earlier this year, the FDA started modifying the labels on prescriptions containing codeine products, as a way to better protect patients from the serious risks associated with opioid medications. The changes made to the label included strict statements explaining that codeine should not be used for any reason, including treatment of cough, by children younger than 12-years-old.

FDA opioid safety tips

The FDA has provided tips for consumers on how to safely treat a child’s cold without the use of medicines. You should be mindful of the directions on non-prescription cough and cold products as well, since they may contain codeine. Pediatricians say, non-drug treatments for coughs include drinking plenty of fluids, especially warm drinks to soothe the throat.

The FDA says most young children don’t need medicines to treat their cough or cold. They say that over-the-counter drugs should not be used to treat cough or cold in children younger than two, because they could cause serious and potentially life-threatening side effects.

Call a doctor if you see any of the following symptoms

  • A fever in an infant 2 months or younger
  • A fever of 102 degrees or higher, at any age
  • Signs of labored breathing, including nostrils widening with each breath, wheezing, fast breathing, the ribs showing with each breath
  • Blue lips
  • Not eating or drinking, with signs of dehydration
  • Ear pain
  • Excessive crankiness or sleepiness
  • If the cough lasts for more than three weeks
  • If the child is getting worse

The FDA plans to have a robust discussion at the meeting and plans to continue sharing updates with the public on how the agency is making treatments safer.

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