FDA expands opioid safety warnings on cough, cold medications

Scott Gottlieb, MD
Scott Gottlieb

The FDA is attempting to combat pediatric exposure to cough and cold medicines containing opioids by requiring changes to safety labeling on these medications, according to a release issued by the organization.

New labeling mandated by the FDA would limit the use of these medications, which may contain codeine and hydrocodone, in children aged younger than 18 years. This decision was made, according to the organization, because the risks associated with pediatric opioid ingestion outweigh the benefits of treatment.

“Given the epidemic of opioid addiction, we are concerned about unnecessary exposure to opioids, especially in young children,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “We know that any exposure to opioid drugs can lead to future addiction. It has become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that do not justify their use in this vulnerable population.”

The updated labeling required by the FDA regarding pediatric patients follows a revision made in 2017, which involved the inclusion of a contraindication placed on codeine-containing products for the treatment of pain, cough or cold symptoms. This update concerned ingestion by children aged younger than 12 years, who have an increased risk of ultra-rapid metabolism.

This most recent development was supported by a panel of experts from the Pediatric Advisory Committee who assessed the risks of codeine and hydrocodone use in children aged under 18 years. Members of the committee concluded that cough or cold experienced as a result of upper respiratory infection does not entail the use of these medications, although treatment may be necessary in some children.

Additional changes that will be required by the organization include an expanded and updated boxed warning for adults that highlights potential misuse, abuse, addiction, slowed or difficult breathing, and overdose and death that may occur from using opioid-based cough and cold medications. This labeling will provide consistency in the warnings featured on opioid-based medications, which are already available on immediate-release opioid analgesics and extended-release and long-acting opioid analgesics.

Parents are advised to speak with their child’s health care provider about alternative treatment options if they are already receiving cough or cold medication containing codeine or hydrocodone. Additionally, those who are caring for children with cough or cold symptoms should examine labels on over-the-counter products for codeine, which are available in some states.

“It is critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone,” Gottlieb said in the release. “At the same time, we are taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products.” – by Katherine Bortz

Disclosures: Infectious Diseases in Children was unable to confirm relevant financial disclosures prior to publication.

Scott Gottlieb, MD
Scott Gottlieb

The FDA is attempting to combat pediatric exposure to cough and cold medicines containing opioids by requiring changes to safety labeling on these medications, according to a release issued by the organization.

New labeling mandated by the FDA would limit the use of these medications, which may contain codeine and hydrocodone, in children aged younger than 18 years. This decision was made, according to the organization, because the risks associated with pediatric opioid ingestion outweigh the benefits of treatment.

“Given the epidemic of opioid addiction, we are concerned about unnecessary exposure to opioids, especially in young children,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “We know that any exposure to opioid drugs can lead to future addiction. It has become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that do not justify their use in this vulnerable population.”

The updated labeling required by the FDA regarding pediatric patients follows a revision made in 2017, which involved the inclusion of a contraindication placed on codeine-containing products for the treatment of pain, cough or cold symptoms. This update concerned ingestion by children aged younger than 12 years, who have an increased risk of ultra-rapid metabolism.

This most recent development was supported by a panel of experts from the Pediatric Advisory Committee who assessed the risks of codeine and hydrocodone use in children aged under 18 years. Members of the committee concluded that cough or cold experienced as a result of upper respiratory infection does not entail the use of these medications, although treatment may be necessary in some children.

Additional changes that will be required by the organization include an expanded and updated boxed warning for adults that highlights potential misuse, abuse, addiction, slowed or difficult breathing, and overdose and death that may occur from using opioid-based cough and cold medications. This labeling will provide consistency in the warnings featured on opioid-based medications, which are already available on immediate-release opioid analgesics and extended-release and long-acting opioid analgesics.

Parents are advised to speak with their child’s health care provider about alternative treatment options if they are already receiving cough or cold medication containing codeine or hydrocodone. Additionally, those who are caring for children with cough or cold symptoms should examine labels on over-the-counter products for codeine, which are available in some states.

“It is critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone,” Gottlieb said in the release. “At the same time, we are taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products.” – by Katherine Bortz

Disclosures: Infectious Diseases in Children was unable to confirm relevant financial disclosures prior to publication.

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