Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes

From Drugs.com - January 11, 2018

Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes

Audience: Family Practice, Pediatrics

[Posted 01/11/2018]

ISSUE: FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18. FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning, the most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.

Some codeine cough medicines are available OTC in a few states, and FDA is also considering regulatory action for these products.

FDA is taking this action after conducting an extensive review and convening a panel of outside experts. Both of these determined the risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.

See the FDA Drug Safety Communication for a list of prescription cough and cold medicines containing codeine or hydrocodone

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