The Food and Drug Administration (FDA) has announced an upcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) which will focus on the pediatric use of prescription cough medicines that contain opioids such as hydrocodone and codeine. Specifically, this panel of independent experts will discuss the the benefits and risks associated with the use of these products in this patient population as well as current treatment practices.
“It is vital we understand the potential complications that can occur when using opioid-containing medications in children, even according to labeled instructions,” said FDA Commissioner Scott Gottlieb, MD, “This is an area that the agency is continuing to evaluate.”
In April 2017, the FDA issued a safety communication to healthcare professionals limiting the use of codeine and tramadol medications in children, as well as recommending against the use of these drugs in breastfeeding mothers. Manufactures of these products were instructed by the FDA to make changes to the prescribing information reflecting these limitations, including a new contraindication stating that codeine should not be used for any reason in children under 12 years of age.
At a meeting held earlier this year, members from the American Academy of Pediatrics and the American Academy of Family Physicians discussed appropriate treatment options for cough in children based on length and severity of symptoms. The participants agreed “that treatment of cough with opioid-containing products was not appropriate and that alternative treatments for cough would differ depending on the age of the child.” Some even suggested that removing cough treatment as an indication may reduce the pressure that some clinicians may feel to prescribe these drugs.
“We look forward to a robust discussion at the meeting this fall and will continue to share updates with the public on the steps the agency is taking to address this important issue,” said Dr. Gottlieb.
For more information visit FederalRegister.gov.