FDA to stress opioids’ risk of overdose, death in new medication safety labels

The Food and Drug Administration will soon require prescription opioid manufacturers to include stronger language on the medications’ labels warning that higher doses and longer-term use carry risks including overdose and death. 

The action, announced Thursday, comes nearly three months after a pair of FDA advisory committees met to discuss the results of two post-market studies of opioids that attempted to quantify the risks of long-term opioid use. And it comes nearly 30 years after the initial approval of OxyContin, the now-infamous painkiller sold by Purdue Pharma, whose aggressive marketing and oversupply helped drive the first wave of the opioid epidemic. 

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