Magazine article Clinical Psychiatry News

FDA Calls for Boxed Warnings on Short-Acting Opioids

Magazine article Clinical Psychiatry News

FDA Calls for Boxed Warnings on Short-Acting Opioids

Article excerpt

The Food and Drug Administration will require boxed warnings on the risks of abuse, misuse, addiction, overdose, and death for all immediate-release opioids.

The decision is part of the latest wave of efforts by federal officials to combat the ballooning opioic epidemic. It comes a week after the Centers for Disease Control and Prevention issued guidelines recommending nonopioid analgesia for noncancer pain, and 3 years after FDA required boxed warnings for all extended-release opioids, Dr. Douglas Throckmorton, deputy director of regulatory programs at the FDA Center for Drug Evaluation and Research, said during a news conference.

The FDA has faced criticism for doing too little, too late to curtail opioid-related deaths, which have surpassed motor vehicle accidents as the leading cause of injury-related fatality in the United States. The agency initially limited its boxed warning to extended-release opioids because they contain more drug per tablet, are more attractive to substance abusers, and have a longer temporal risk of potentially fatal respiratory depression, Dr. Throckmorton said.

"This change will remind prescribers that immediate-release opioids are also powerful drugs with important safety concerns," he said. "We will continue to monitor the situation, and as we need to do more, we will."

The new boxed warning requirement affects 87 innovator products and 141 generic immediate-release opioids, whereas the 2013 decision involved just 8 long-acting products. The FDA notified manufacturers of its decision and expects to finish reviewing label updates by the end of 2016, officials said. …

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