FDA mandates new safety warnings for opioid pain medicines
April 13 (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.
Privately held Alora Pharmaceuticals' Dsuvia and Collegium Pharmaceuticals' (COLL.O) Nucynta are among opioid pain relievers currently sold in the United States.
Our Standards: The Thomson Reuters Trust Principles.