FDA Releases New Requirements For Prescription Opioid Cough And Cold Medicines

FDA revises labelling in prescription cough and cold products to protect children from opioids

The revised safety warnings on these products will be consistent with the labeling of other opioid-containing drug products, such as immediate-release opioid analgesics and extended-release and long-acting opioid analgesics, according to the FDA. 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.

The Food and Drug Administration released a statement Thursday saying it will require changes to safety labels on prescription opioid cough and cold medicines that contain codeine or hydrocodone, citing the "serious risks" these medicines pose to children. The FDA's safety announcement also recommended that breastfeeding women avoid the products, "due to possible harm to their infants".

After safety labelling changes are made, these products will no longer be indicated for use to treat a cough in any paediatric population and will be labelled for use only in adults aged 18 years and older.

A new Contraindication to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. Slowed or hard breathing can also result from exposure to codeine or hydrocodone.

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Codeine is a pain reliever that is sometimes used in combination with other medications to treat severe cough, according to the FDA. FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or hard breathing to the Boxed Warning, the most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.

Health care professionals should be aware that FDA is changing the age range for which prescription opioid cough and cold medicines are indicated.

"It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone". Cough is often secondary to infection, not serious, and usually will get better on its own so treatment may not be necessary. 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. Caregivers should also read labels on non-prescription cough and cold products. If you notice any of these signs, stop giving the medicine and seek medical attention immediately by going to an emergency room or calling 911.

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