STORY FROM: Drugs & Medical Devices
FDA Orders Label Changes for Opioid-Containing Prescription Cough, Cold Medicines
January 12, 2018
WASHINGTON, D.C. — The Food and Drug Administration has ordered the makers of prescription cough and cold medicines containing opioids such as codeine or hydrocodone to change their labels in order to limit the use of those products to adults 18 years and older.
In a Jan. 11 Drug Safety Communication, the FDA explained that the risk of those medicines outweigh their benefits in children younger than 18.
The agency says it is also requiring the addition of a Boxed Warning to cough and cold medicines containing codeine or hydrocodone about “the risks of misuse, abuse, addiction, overdose, death, and ...