The Pediatric Advisory Committee of the US Food and Drug Administration (FDA) voted unanimously (24 no, 0 yes) that the benefit/risk is not favorable for use of prescription codeine cough suppressants for treatment of cough associated with allergy or the common cold in pediatric patients aged 12 years to younger than 18 years of age.
The committee voted by a majority that the benefit/risk is not favorable for use of hydrocodone cough suppressants for treatment of cough associated with allergy or the common cold in pediatric patients aged 6 years to younger than 12 years (23 no, 1 yes) or in pediatric patients aged 12 years to younger than 18 years (23 no, 1 yes).
The committee voted by a large margin (21 no, 2 yes, 1 abstain) that the benefit/risk is not favorable for use of prescription opioid cough suppressants for treatment of cough in pediatric patients.
Opioids can cause respiratory depression, and children are particularly vulnerable. Labels on products containing opioids warn about this risk in children. Other risks include misuse, abuse, addiction, overdose, and death.
The committee was not asked to consider whether these products are effective because the FDA has already determined that they are. Rather, they were expected to consider their risks and benefits. Nevertheless, panel members repeatedly said there is insufficient evidence to support the use of opiates, particularly codeine, for allergies and common colds in children.
In addition, suppression of cough in children with a common cold — a brief, self-limiting symptom — is not recommended.
Codeine Particularly Concerning
In 2013, the FDA warned about the potential for respiratory depression in children when such products are given after procedures such as tonsillectomy. At that time, the FDA decided to add a boxed warning to its labeling for codeine-containing products and a contraindication warning against its use for postoperative pain relief.
In April 2015, the European Medicines Agency followed the recommendations of its Pharmacovigilance Risk Assessment Committee and restricted the use of codeine for cough in children.
The American Academy of Pediatrics said clinicians and parents should stop giving codeine to children. Other medical groups, including the World Health Organization, have warned about adverse effects associated with the use of codeine in children, especially those younger than 12 years.
“I don’t think that we’ve proven efficacy in the particular circumstances listed; I think we should follow the pediatric guidelines for treatment of cough, and I don’t think this precludes the use in exceptional circumstances where it might be useful,” said voting committee member Michael White, MD, PhD, pediatric cardiologist, Ochsner Health System, New Orleans, Louisiana.
Several committee members said it’s time to stop the use of codeine for cough in children, period; more than one said they never use it for that purpose in clinical practice or in their own children.
“This is really historic and antiquated cough medicine,” said voting panel member Kelly Wade, MD, PhD, attending neonatologist, Department of Pediatrics, Children’s Hospital of Philadelphia, Pennsylvania.
“No” to Hydrocodone as Well
Most committee members felt the risks outweigh the benefits for use of hydrocodone for treatment of cough associated with allergies and common colds in children aged 6 years to younger than 18 years.
Several members mentioned concern about the potential for misuse or abuse by adolescents. “I voted ‘no,’ largely because of the concern of using opioids in adolescents,” said voting committee member Christy Turer, MD, assistant professor of pediatrics, clinical sciences and medicine, University of Texas Southwestern, Dallas.
“I voted ‘yes’ because the risk is relatively low; most of the problems were in those less than 6 years of age, and I’ve personally seen benefits from the use of it in practice,” said consulting voting member Kort Delost, RPh, pharmacist, Bountiful Drug, Bountiful, Utah, of his votes that the benefits outweigh the risks.
Opioids Not Recommended for Cough Suppression in Pediatric Patients
The committee voted by a large margin against the use of opioids for treatment of cough in children in general. Some felt that question was too broad and voted “no” because of their discomfort with the use of codeine or because suppression of cough in children with a common cold — a brief, self-limiting symptom — is not recommended.
“I voted ‘no,’ focusing my attention on the fact that this was about cough suppression, and not treatment, and in that context there are suppressants of equal efficacy with fewer side effects than narcotics,” voting committee member Peter Havens, MD, MS, director, Pediatric HIV Care Program, Children’s Hospital of Wisconsin, and professor, pediatric and population health, Medical College of Wisconsin, Milwaukee, said.
Other panel members agreed that clinicians could still prescribe opioids for cough in children under certain circumstances if they desire.
The committee members have disclosed no relevant financial relationships.
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