The U.S. Food and Drug Administration (FDA) posted a Drug Safety Communication on January 11 announcing that it is restricting the use of opioid-based cough and cold medications to adults over 18, warning that the drugs are too dangerous to be given to children.

The labels will be updated to reflect these restrictions on all cough-and-cold medications that contain hydrocodone and codeine.

In a press release, FDA Commissioner Scott Gottlieb warned:

Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction.”

Gottlieb warned that opioid medicines for cough-and-cold pose “serious risks that don’t justify their use in this vulnerable population.”

Last year, the FDA contraindicated all opioid medications for children under 12 years old. The agency also warned against prescribing opioids to children between 12 and 18 years old with certain health problems, such as lung disease or obstructive sleep apnea.

The new rules against giving opioid cough-and-cold medications are far more strict, indicating that the FDA is very concerned about the potential for abuse and overdose. The side effects of opioids may include drowsiness, dizziness, nausea, vomiting, and constipation.

In high doses, opioids can also depress the central nervous system, resulting in respiratory depression (slowed breathing) and death.

The medications affected by the FDA’s new warnings include Tuxarin ER, Tuzistra XR, Triacin C, FlowTuss, Obredon, Hycofenix, Rezira, Tussionex, Pennkinetic, Vituz, Zutripro, and generic medications.

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

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