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FDA to require boxed warnings on opioid medications

March 22, 2016 Silver Spring, Md. — As part of the government's commitment to ending the U.S. opioid epidemic, the Food and Drug Administration announced March 22 major label changes for all prescription opioid products, including new boxed warnings about the serious risks of misuse, abuse, addiction, overdose and death.

The FDA also said it will require several more safety labeling changes to include additional information on the risk of these medications as part of the agency's efforts to "help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain," according to an FDA release.

"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," said Robert Califf, M.D., FDA commissioner. "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."

Opioid pain medications, such as hydrocodone and oxycodone, are a leading source of drug abuse in the United States. As prescribers of these painkilling medications, the ADA believes dentists have a role to play in preventing their diversion, misuse, and abuse. The ADA has long encouraged continuing education about the appropriate use of opioid pain medications in order to promote both responsible prescribing practices and limit instances of abuse and diversion.

According to FDA, prescription opioids are divided into two main categories: immediate release products intended for use every four to six hours; and extended-release/long-acting products, which are primarily intended to be taken once or twice a day.

As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated using protocols developed by neonatology experts.

Additionally, in the March 22 Drug Safety Communication, FDA outlined its plans to require labels to include safety information about opioids and their potentially harmful drug interactions with other medicines. This includes a serious central nervous system condition called serotonin syndrome as well as information on the effects opioid abuse can have on the endocrine system, including a rare but serious disorder of the adrenal glands and decreased sex hormone levels.

The agency also said it is "carefully reviewing" all available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids.

In October 2015, the White House announced a multi-agency initiative aimed at combatting opioid abuse and other forms of drug abuse. The Association has pledged to provide training on opioid prescribing in the next two years as part of the American Medical Association Task Force on this issue. To date, more than 66,000 providers have completed prescriber training, putting the task force on pace to meet that goal, according to the release.

For more information about opioids, including upcoming webinars and prescriber tips, visit