FDA Puts New Limits on Opioids in Kids' Cough Meds

FDA Puts New Limits on Opioids in Kids' Cough Meds

The agency said it is requiring manufacturers to change the wording on their labels to make clear that such products should not be used for anyone younger than 18.

Prescription opioid cough and cold medicines that contain codeine or hydrocodone are being stripped of their indications to treat cough in kids, FDA announced Thursday (Jan. 11).

Products covered by Thursday's announcement included four with codeine, in combination with other agents such as chorpheniramine and promethazine, and five with hydrocodone along with other ingredients.

The newly updated Boxed Warning on these medicines will also warn adult users "about the risks of misuse, abuse, addiction, overdose and death, and slowed or hard breathing that can result from exposure to codeine or hydrocodone", the agency added.

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The label change also proceeds a pediatric restriction set previous year that required a contraindication to prescription codeine product labels. We know that any exposure to opioid drugs can lead to future addiction.

The decision to limit the prescription opioid cough and cold medicine availability for pediatric patients was based on extensive data review and advisory committee input.

Thursday's move expands on actions taken in April 2017, when the agency strengthened its warning on products containing codeine or tramadol for the treatment of cough and pain, adding a contraindication for children under the age of 12. Common side effects of opioids include headache, dizziness and vomiting.

According to the agency, outside experts said that while some children's coughs require treatment, many get better on their own - including ones that are the result of respiratory infections. "If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine", it said.

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