FDA Releases New Requirements For Prescription Opioid Cough And Cold Medicines

FDA changes label safety requirements on prescription opioid, cough medicines

Health Alert: FDA warns of opioids in cold medicines

As a result, FDA is requiring several changes to the labels of all prescription medicines containing these drugs.

Cough medications that contain opioids like codeine should never be given by kids, and the medicines will now need to be labeled to make that clear, the Food and Drug Administration said Thursday.

"Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children", said Scott Gottlieb, MD, FDA commissioner. 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. "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", the FDA said.

According to the FDA, labeling for adult-only use of prescription opioid cough and cold medicines that contain codeine or hydrocodone will also now include updated safety information.

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.

A new Warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.

In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said. Information about these required safety labeling changes are being made available to parents and health care professionals through a Drug Safety Communication. The FDA's safety announcement also recommended that breastfeeding women avoid the products, "due to possible harm to their infants".

The FDA pointed to known side effects of opioid medications, including "drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache". After the safety labeling changes are made, the products will no longer be indicated for use to treat coughs in any pediatric population.

"The opioid epidemic has many origins, but can begin with exposure to [opioids] at young ages", he said.

Gottlieb said in a statement in August that the FDA would be meeting with the Pediatric Advisory Committee to further evaluate the use of prescription opioid products containing hydrocodone or codeine to treat cough in children.

"It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment". Parents of children now prescribed a cough and cold medicine containing codeine or hydrocodone are encouraged to talk to their child's health care professional about other treatment options.

The American Academy of Pediatrics has been warning about codeine since 1997.

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