FDA to require stronger warnings on some prescription painkillers

WASHINGTON — Some prescription painkillers will be required to include new warnings on their labels about the risk of abuse and overdose, the Food and Drug Administration announced Tuesday.

The agency said that all immediate-release prescription opioids — drugs that are usually prescribed to treat short-term pain, like Vicodin — must have a new boxed warning on their labels about the risk of abuse, addiction, overdose, and death. Boxed warning labels are the strongest kind the FDA requires.

“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” Dr. Robert Califf, the FDA’s new commissioner, said in a statement.

In addition, the FDA is requiring all opioids, including extended-release drugs like Oxycontin that treat chronic pain over a longer period, to include on their labels new warnings about the potential risks of complications if the painkillers are taken at the same time as other medications.

The agency’s announcement comes the week after the Obama administration announced new guidelines intended to encourage doctors to prescribe fewer strong painkillers as another means of fighting the opioid abuse epidemic. Congress also recently passed legislation to combat painkiller addiction, though Capitol Hill remains divided over how much funding to funnel to the fight.

A STAT-Harvard poll released last week found that Americans were evenly divided when assigning blame for the crisis: 37 percent said individual abusers are responsible, while 34 percent said the biggest problem is doctors who inappropriately prescribe painkillers.