FDA mandates new safety warnings for opioid pain medicines

[April 14, 2023]  (Reuters) - The U.S. Food and Drug Administration said on Thursday it will require new safety warnings to be added in the prescribing information on labels for opioid pain relievers, including a warning about increased sensitivity to pain.

FDA said data suggests patients who use opioids for pain relief after surgery often have leftover tablets, which puts them at risk for addiction and overdose.

The updated safety warnings for these drugs will provide clarity about which patients opioid pain drugs should be prescribed to and the appropriate dosage and administration, the health regulator said.

Among other changes, the new labeling would also have to carry a warning that risk of overdose increases with higher dosage and that immediate-release opioids should not be used for an extended period unless a patient's pain remains severe.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Privately held Alora Pharmaceuticals' Dsuvia and Collegium Pharmaceuticals' Nucynta are among opioid pain relievers currently sold in the United States.

(Reporting by Aditya Samal and Bhanvi Satija in Bengaluru)

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