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FDA ExpertFDA Expert Roundtable Meeting on the Use of Cough Suppressants in Children

11 May 2017 12:44 PM | Monique Ochoa (Administrator)

FDA Expert Roundtable Meeting on the

Use of Cough Suppressants in Children

I was recently privileged to serve as the PA representative on a Food and Drug Administration roundtable to discuss the use of cough suppressants in children, with particular attention to opioid containing antitussives.  In addition to the AAPA and SPAP, there were representatives from many organizations including the American Academy of Pediatrics, American Thoracic Society, American College of Chest Physicians, National Association of Pediatric Nurse Practitioners, and American College of Emergency Medicine.

The FDA was seeking current practice and treatment guidelines from clinicians surrounding the use of cough suppressants in children.  There have been a number of studies looking at the use of over-the-counter and prescription cough and cold formulations in the pediatric population revealing limited evidence regarding the efficacy of these drugs.1,2  There has also been some concern regarding the safety of these drugs.1  Both the American Academy of Pediatrics and the American College of Chest Physicians have advised against the use of cough and cold medications in young children under the age of 4 years.3,4

In response to a growing epidemic of opioid abuse, the FDA was further seeking current practice to reassess its approach to opioid medications in general.  There are known safety issues with the use of codeine in children particularly respiratory depression.5  There is further limited evidence on the efficacy of codeine for cough suppression.6

The panel was overwhelmingly against the use of codeine in children, especially those under the age of 12 years, or in any child with a chronic respiratory disorder, i.e. asthma, cystic fibrosis.  It was even suggested by the panel that the opioid containing antitussives simply be removed from the market.  There was a lot of discussion about the role and value of suppressing a cough in children.  Consensus was that there are very rare instances where there is any need to suppress a cough.  The focus on treating a cough should be aimed at the underlying etiology and using bronchodilators, steroids, antibiotics, or other medications appropriately to treat that cause. 

It was recognized that in the primary care setting, and frequently in the emergency room or urgent care settings, that parents and caregivers want something to treat the cough.  Health Care Providers would need to focus on educating families on the ineffectiveness of cough suppressants, and the frequently self-limited nature of the cough especially in viral upper respiratory infections.  Honey was cited as a safer alternative for treating cough.7

The AAP released a clinical report in October 16 calling for a contraindication for the use of codeine in children for pain or for treatment of cough.5  Most recently, in April 2017, the FDA revised its restriction on the use of codeine to a contraindication to using codeine to treat pain or cough in children under the age of 12 years.  The FDA went further by issuing a warning against using codeine between the ages of 12 and 18 years in patients who are obese or have conditions such as obstructive sleep apnea or lung disease.8

Cough is the most common chief complaint in the United States and carries a large burden in time and treatment costs.9  Unfortunately, in children there are no existing effective treatments for cough other than those aimed at treating the underlying cause.  The value of cough suppression itself is questionable.  Opioid containing antitussive medications should not be used to treat cough especially in pre-adolescence or in the presence of obesity, OSA, or lung disease.

  • 1.       Carr, B. Efficacy, abuse, and toxicity of over-the-counter cough and cold medicines in the pediatric population. Current Opinion in Pediatrics. 2006, 18:184-188.
  • 2.       Smith, SM, et al.  Over-the-counter (OTC) medications for acute cough in children and adults in community settings. Cochrane Database Syst Rev. Nov 2014, (11).
  • 3.       Lowry, J. Leeder, J. Over-the-counter Medications : Update on Cough and Cold Preparations.  Pediatrics in Review. July 2015, 36(7).
  • 4.       Chang, A; et al.  Guidelines for Evaluating Chronic Cough in Pediatrics.  Chest. Jan 2006, 129:1(suppl).
  • 5.       Tobias, J; et al.  Codeine: Time to Say “No”. Pediatrics. Oct 2016, 138(4).
  • 6.       Gardiner, S; et al.  Codeine versus placebo for chronic cough in children. Cochrane Database Syst Rev. 2016, (7).
  • 7.       Oduwole, O; et al.  Honey for acute cough in children.  Cochrane Database Syst Rev. Dec 2014, (3).
  • 8.       https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm
  • 9.       McNamara, M. Cough. The 5 Minute Pediatric Consult. 6th edition. Philadelphia: Wolters Kluwer. 2012. 230-231.

Brian R Wingrove, MHS, PA-C, DFAAPA

Past President, Society for PAs in Pediatrics

Children’s Physician Group – Pulmonology at Scottish Rite

Children’s Healthcare of Atlanta


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