FDA toughens safety labels for painkillers

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The Food and Drug Administration (FDA) is stepping up the safety warnings on the labels of powerful painkillers amid a national epidemic of drug overdoses.

Drug companies will now have to include specific warnings about “serious risks of misuse, abuse, addiction, overdose and death” on all immediate-release painkillers like oxycodone and codeine. The change will affect 228 medications, according to the FDA.

{mosads}Dr. Robert Califf, the newly confirmed head of the FDA, called the new policy one of the strongest steps yet to warn patients and providers about the link between painkillers and addiction. But he also made clear that he wasn’t going after the drug companies alone.

“I don’t mind being relatively explicit about this. We really need practicing docs to step up to the plate here,” Califf told reporters Tuesday.

As recently as the day of his confirmation, Califf defended the FDA’s drug labels as “pretty clear and strong.” The bigger problem, he said, was doctors who have “gotten in the habit of prescribing more opioids than they should.” 

Califf was confirmed in February with unanimous support of Senate Republicans, who favored his background in the pharmaceutical sector. Two Senate Democrats, Sens. Ed Markey (Mass.) and Joe Manchin (W.Va.), opposed Califf’s nomination, criticizing his approach to fighting opioid abuse as too lax. 

The FDA has been stepping up its outreach to patients and doctors about the potentially lethal effects of using painkillers after the number of overdoses reached a record high in 2014. 

Last month, the FDA announced a “sweeping review” of its opioid policies in an attempt to quash criticism that the agency has reacted too slowly to the issue — and to help Califf’s confirmation in the Senate.

In a statement on Tuesday, Markey called the FDA’s new rules “too little too late” and repeated his calls for more education requirements for painkiller-prescribing doctors and an outside agency to review all painkillers before they’re approved for use. 

The Centers for Disease Control and Prevention (CDC), which has faced similar outcry from advocacy groups, also announced last week that it would be tightening the rules on prescribing for potentially addictive drugs.

– Updated at 3:28 p.m.

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