FDA evaluating prescription opioid medications approved to treat cough in children

The United States Food and Drugs Administration (US FDA) says that parents need to be aware of the information regarding treatment of symptoms of cough and cold in their children in order to ensure their health and safety.

There are two scenarios when a child suffers from symptoms of cough and cold says the FDA press release. One of these is when the symptoms are severe enough to mandate prescription medication without which no relief would be found. These prescription medications come with their own risks, more importantly among younger children. Many of these medications contain opioids that may pose health risks for the younger children for example. The other scenario is when no medication is required at all.

Earlier this year the FDA in a roundtable meeting included professional expert groups including representatives from American Academy of Pediatrics and the American Academy of Family Physicians addressed this issue about the use of cough suppressants, particularly those that contain opioids, especially in children. The meeting focused on determining the right treatment in these situations based on the duration as well as severity of the clinical picture. Treatment should be aimed at the underlying cause of the symptoms rather than quietening the cough alone found the team. Other medications that addressed the underlying cause may be more appropriate said the experts on the table. In addition non-drug therapies may be more appropriate when it is just the symptoms that are causing the problem.

This week on the 21st of August 2017, thus the FDA released a statement to the press stating that this complex issue would be carefully considered. An upcoming meeting of the Pediatric Advisory Committee was announced. This team would focus on the use of prescription opioid products used for cough suppression in children that contained hydrocodone or codeine. The team of experts would analyze and assess the current treatment practices in these situations and also look at the benefits and risks associated with such prescription medication use in children. This group of independent experts could provide valuable inputs that can help FDA draft better decision making algorithms for these situations.

The press release also spoke about the possible complications that are associated with opioid use in children. These complications may occur despite following labeled instructions say experts. To address the possible harm these medications could cause, the FDA this year in April had suggested changes in the labeling of prescription codeine products. This was a step to protect children from the serious risks that are linked to these opioid medications including lethal respiratory depression that could cause deaths. The labels were mandated to carry a warning about the drug containing codeine saying it should not be used in treatment of cough in children younger than 12 years.

The FDA in another step towards safe use of medications has provided tips for parents and caregivers who are dealing with children with cough and cold. One of the advices include the fact that most of these conditions are self-limiting, meaning no actual treatment or medication may be required. All caregivers are urged to read the medication labels before administering them to their children. Research is being funded to ensure best practices for the safe use of pediatric cough and cold medications that re more consumer centric and complete to enhance not only opioids but also other medications used in cough and cold.

Dr. Ananya Mandal

Written by

Dr. Ananya Mandal

Dr. Ananya Mandal is a doctor by profession, lecturer by vocation and a medical writer by passion. She specialized in Clinical Pharmacology after her bachelor's (MBBS). For her, health communication is not just writing complicated reviews for professionals but making medical knowledge understandable and available to the general public as well.


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