FDA Extends Required Warnings to Short-Acting Opioid Painkillers

By Natalie Grover | March 23, 2016

Short-acting opioid painkillers will carry strong new warnings under U.S. Food and Drug Administration requirements announced on Tuesday that will bring information about addiction and abuse in line with that on long-acting pills.

The FDA’s action comes a week after the U.S. Centers for Disease Control and Prevention recommended doctors prescribe non-opioids, including acetaminophen and ibuprofen, for patients with pain unless they have active cancer or are receiving end-of-life care.

Short-acting opioids account for 90 percent of prescribed opioids, the FDA said. The new labeling will affect 87 branded products and 141 generics ranging from combination acetominophen-opioid pills to intravenous formulations. The new warnings include the risks of abuse, addiction, overdose and death.

The move is one of a series announced recently by the FDA as it seeks to tackle the problem of opioid overdose and death. Nearly 2 million Americans aged 12 or older either abused or were dependent on prescription opioids in 2014, according to the Centers for Disease Control and Prevention.

The new labels will state that short-acting opioids, which are intended for use every four to six hours, should be used only when alternative treatments are inadequate or cannot be tolerated. They will also warn that chronic use during pregnancy can cause newborns to suffer potentially deadly withdrawal symptoms.

In 2013, the FDA announced labeling changes to long-acting opioids. Those are given for pain severe enough to require daily, round-the-clock treatment and contain more drug per tablet than immediate-release tablets.

The latest requirement brings the labels for all opioids into alignment.

“The label is a very important construct on which a lot of other things are based,” FDA Commissioner Robert Califf told reporters on a conference call. “I’m certain that this will have an impact.”

In May, the FDA will hold an advisory committee meeting where it will discuss the impact of changes made to the long-acting opioid labels that were made in 2013.

The agency said it would also require several additional safety labeling changes across all prescription opioid products to include information on the risk of those medications.

(Reporting by Natalie Grover; Additional reporting by Ankur Banerjee in Bengaluru and Toni Clarke in Washington; Editing by Anupama Dwivedi and Peter Cooney)


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