Cold Medication With Opiates Not Safe For Children, FDA Announces

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Cold Medication With Opiates Not Safe For Children, FDA Announces

The Food and Drug Administration (FDA) has mandated a safety label change for cough and cold medication that include opioids or opiates, and state that they should no longer be given to patients under than the age of 18.

The agency also noted that it might enact new limitations on the prescription dose and duration of other opioid medications.

This action includes nine different cough and cold medications – four that contain codeine, and five that contain hydrocodone. They include such brand names as Tuxarin ER, Tuzistra XR, Triacin C, FlowTuss and Zutripro, and several that are available in generic form.

The FDA says it made its decision after undergoing an extensive review of the products which was analyzed by a panel of outside experts. They determined that the risk of slowed breathing, abuse, addiction, and death with these drugs outweighed the benefits regarding patients under age 18:

“These products will no longer be indicated for use in children, and their use in this age group is not recommended. Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated.”

The FDA will also be requiring stronger warning labels on cough/cold medications containing opioids to make them consistent with such warnings that are typically found on prescription painkillers.

The FDA also issued its 2018 Strategic Policy Roadmap, which highlights four prioritized areas for the upcoming year. The first objective is to reduce the misuse of opioid medication, as addiction and overdoses are killing people at an incredible rate of 91 per day.

They did not point out, however, that most of those deaths are now related to illicit opioids such as fentanyl and heroin:

“Too many people are being inappropriately prescribed opioid drugs. When these prescriptions are written, they are often for long durations of use that create too much opportunity for addiction to develop.”

Of note, several states have already imposed limitations on the dose and/or duration of opioid prescriptions for acute pain.

You can view the entire list of drugs included in the FDA’s list here.

~ G. Nathalee Serrels, M.A., Psychology


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