FDA to take closer look at opioids in pediatric cough suppressants

The FDA announced today that it will hold a meeting on Sept. 11 to discuss cough medications in children because some may have opioids as an ingredient, according to a press release.

“There are few more common decisions that parents and providers are asked to make than the question of how to appropriately treat a child’s cough and cold symptoms,” FDA commissioner Scott Gottlieb, MD, said in a statement. “Sometimes symptoms can be severe enough that prescription medication is needed, but some of these medications pose their own risks — especially for younger children — because they may contain opioids. Other times medication might not be necessary at all.”

According to the statement, a meeting with AAFP and AAP on the use of cough suppressants — especially cough suppressants containing opioids — brought up issues such as ascertaining the right treatment based on the seriousness and length of one’s symptoms, determining the symptoms’ cause and potentially using nondrug therapies or medications that may be more fitting the condition.

The meeting of the Pediatric Advisory Committee in September will review the use of prescription opioid products containing codeine or hydrocodone for treating coughs in pediatric patients, such as benefit-risk considerations and treatment procedures presently in place, the agency stated.

“It is vital we understand the potential complications that can occur when using opioid-containing medications in children, even according to labeled instructions,” Gottlieb said. “All of this work is essential to reducing preventable harm from opioid-containing medications and keeping children safe.”

Earlier this year, the FDA mandated changes to the labeling of prescription codeine products to add what the agency stated was a contraindication to drug labels alerting that codeine should not be used for any reason, including treatment of cough, in children younger than 12 years. - by Janel Miller

Disclosure: Gottlieb is FDA commissioner.

The FDA announced today that it will hold a meeting on Sept. 11 to discuss cough medications in children because some may have opioids as an ingredient, according to a press release.

“There are few more common decisions that parents and providers are asked to make than the question of how to appropriately treat a child’s cough and cold symptoms,” FDA commissioner Scott Gottlieb, MD, said in a statement. “Sometimes symptoms can be severe enough that prescription medication is needed, but some of these medications pose their own risks — especially for younger children — because they may contain opioids. Other times medication might not be necessary at all.”

According to the statement, a meeting with AAFP and AAP on the use of cough suppressants — especially cough suppressants containing opioids — brought up issues such as ascertaining the right treatment based on the seriousness and length of one’s symptoms, determining the symptoms’ cause and potentially using nondrug therapies or medications that may be more fitting the condition.

The meeting of the Pediatric Advisory Committee in September will review the use of prescription opioid products containing codeine or hydrocodone for treating coughs in pediatric patients, such as benefit-risk considerations and treatment procedures presently in place, the agency stated.

“It is vital we understand the potential complications that can occur when using opioid-containing medications in children, even according to labeled instructions,” Gottlieb said. “All of this work is essential to reducing preventable harm from opioid-containing medications and keeping children safe.”

Earlier this year, the FDA mandated changes to the labeling of prescription codeine products to add what the agency stated was a contraindication to drug labels alerting that codeine should not be used for any reason, including treatment of cough, in children younger than 12 years. - by Janel Miller

Disclosure: Gottlieb is FDA commissioner.