The FDA Is Beefing Up Warning Labels On Opioid Painkillers

The Food and Drug Administration is buttressing warning label requirements for many addictive opioid drugs, such as Vicodin and Percocet, as part of a broader fight against America’s prescription painkiller and heroin epidemic.

“Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic,” FDA Commissioner Robert Califf said in a statement Tuesday.

As part of the policy shift, instant-release versions of opioid painkillers must carry boxed warnings about “the serious risks of misuse, abuse, addiction, overdose, and death” associated with the treatments. These warnings are already required for many extended-release opiates.

With the broadened rules in place, 87 brand name and 141 generic painkillers will be affected.

Nearly 29,000 Americans died from opioid- and heroin-related drug overdoses in 2014, according to the Centers for Disease Control and Prevention. The spike in heroin addiction and deaths, which many say begins with addiction to legal prescriptions, has catalyzed a backlash against opiates and the pharmaceutical firms which manufacture them—as well as against the FDA, which critics say has been far too lax in approving the therapies.


In fact, that perceived slack by the agency led a small-but-vocal bipartisan group of senators to vote against Califf’s confirmation last month. Sen. Ed Markey (D-Mass.) singled out the agency’s decision to expand the label for popular painkiller OxyContin to some children as a major reason for his opposition.

Markey didn’t seem particularly impressed with Califf and the FDA’s newest efforts.

Boxed warnings “have done little to prevent” addiction, and “it has taken the FDA far too long to address the grave risks of these drugs,” he told the New York Times.

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