FDA Releases New Requirements For Prescription Opioid Cough And Cold Medicines

Share

As a result, FDA is requiring several changes to the labels of all prescription medicines containing these drugs. Cold and cough medicines that contain either codeine or hydrocodone will also have to have the same labels as any other medicine that contains an opioid. "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". These medicines carry serious risks, including slowed or hard breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. Labeling for the medications also is being updated with additional safety information for adult use - including an expanded Boxed Warning, the FDA's most prominent warning - notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or hard breathing that can result from exposure to codeine or hydrocodone. 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.

Not only will these medications get new safety labeling about the age of users, they will also get new labels about safe use in general, said the FDA. Slowed or hard breathing can also result from exposure to codeine or hydrocodone.

The changes in the labeling requirements were decided upon after extensive research on the topic and the safety risks, including advice from experts, said the release from the FDA. Consider recommending over-the-counter (OTC) or other FDA-approved prescription medicines for cough and pain management in children younger than 12 years and in adolescents younger than 18 years, especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems. These new actions further limit the use of these medicines beyond the 2013 FDA restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.

Common side effects of opioid use include headache, vomiting, dizziness, breathing difficulties and even death.

The move comes after a 2017 decision by the FDA to add its strongest warning - a "contraindication" - to labeling for prescription products containing codeine. Experts indicated that although some pediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment. Caregivers should also read labels on non-prescription cough and cold products.

Parents whose children are now prescribed cold or cough medication containing codeine or hydrocodone are encouraged to talk with their doctors about other treatment options.

Share