FDA mandates new safety warnings for opioid pain medicines

Collegium Pharmaceutical

13/04/2023 19:37

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.
    
     

 (Reporting by Aditya Samal and Bhanvi Satija in Bengaluru)
 ((Aditya.Samal@thomsonreuters.com;))