Health Care

FDA Releases New Requirements For Prescription Opioid Cough And Cold Medicines

FDA Releases New Requirements For Prescription Opioid Cough And Cold Medicines”

The FDA announced Thursday that it's requiring revisions to the safety labeling on such prescription opioid cough and cold medicines to indicate that the products no longer can be used to treat children - because their risks outweigh their potential benefits - and should be used only for adults 18 and older.

New safety labeling requirements about who should take prescription opioid cough and cold medicines with codeine or hydrocodone are due to roll out following a United States Food and Drug Administration announcement. These products will no longer be indicated for use in children, and their use in this age group is not recommended.

In September, the FDA met with the Pediatric Advisory Committee to determine the dangers associated with using opioids in children's cough medicine.

Gottlieb also cited the ongoing epidemic of opioid addiction, and stressed the importance of reducing exposure to addictive drugs at a young age. Both of these determined the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18. "At the same time we're taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products".

The required safety labelling changes announced are based on an extensive review of available data and expert advice shared at meetings to explore the paediatric use of an opioid-containing cough and cold products. Labeling changes also address safety information for adults, including an expanded boxed warning indicating the risks of using opioid medications, such as misuse, abuse, addiction, overdose, and death.

Though milder side effects include headaches and vomiting, opioids can cause potentially fatal breathing problems, especially in children, the FDA warns. A year ago the restrictions were expanded to include safety labels that carried the contraindication warning, the FDA's most severe warning, to say that it should not be used for patients under the age of 12. And while they say some kids' cough require treatment, symptoms usually subside on their own. If a cough medicine is prescribed, ask your child's health care professional or a pharmacist if it contains an opioid such as codeine or hydrocodone.

Parents and caregivers should be aware that prescription opioid cough and cold medicines that include codeine or hydrocodone should not be used in children. Always read the labels on prescription bottles.



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