FDA Toughens Label Warning for Popular Opioid Drugs

Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.

By Nathaniel Weixel

March 22 — A new warning about the serious risks of misuse, abuse, addiction, overdose and death will be printed on the boxes of all immediate-release opioid pain medications, under a policy announced by the FDA March 22.

The black box warnings—the most serious type—are part of a larger reassessment on how the agency regulates opioid medications. The warnings will be included on packages of all immediate-release opioid painkillers like morphine and Percocet (acetaminophen/oxycodone). The warnings will be similar to what the Food and Drug Administration required for extended-release and long-acting opioids like OxyContin (oxycodone) in 2013.

Opioids are a class of powerful narcotic pain medicines that are used to treat moderate to severe pain that may not respond well to other pain medicines.

FDA officials told reporters on a March 22 call that the changes will affect the labels of 141 generic drugs and 87 innovator or branded products. Immediate-release opioids are the most commonly prescribed, and make up 90 percent of the opioid market, the FDA said.

Pregnancy, Interaction Warnings

The warning also will require a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening. Also, the FDA will require updated labeling for all opioids to include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition called serotonin syndrome.

The FDA also will require several safety labeling changes across all prescription opioid products to include additional information on their risks.

“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.

During a call with reporters, Califf and Doug Throckmorton, a deputy director in the FDA's Center for Drug Evaluation and Research, said the new warnings should help give doctors more information to better prescribe opioids.

“This new indication, once finalized, will remind prescribers that immediate-release opioids are also powerful drugs with important safety concerns,” Throckmorton said.

Califf added the new warnings will help, but the FDA can't regulate how doctors practice medicine. “We want prescribers to use their clinical judgment” to best implement the label recommendations, Califf said. “We need practicing docs to step up to the plate.”

The FDA's announcement comes just a week after the Centers for Disease Control and Prevention published new prescribing guidelines on opioids to curb an overdose epidemic that the CDC has linked to increased prescribing and sales of opioids.

Senate Criticism

The FDA and Califf in particular have come under fire from some senators who have been highly critical of Califf's role in what they said is an underwhelming agency response to the prescription opioid epidemic. Califf was recently confirmed as the FDA's leader , but not before some senators delayed the nomination over drug safety concerns.

Sens. Edward Markey (D-Mass.) and Joe Manchin III (D-W.Va.) placed holds on Califf's nomination and ultimately voted against confirmation once the vote occurred.

Markey's reaction to the FDA's March 22 announcement was mixed.

“Today’s announced changes to the labels of opioid products will finally reflect what we have known about these drugs for decades—they are dangerous and addictive and can lead to dependency, overdose and death,” Markey said in a March 22 statement. “Unfortunately, it has taken FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone.”

Markey pledged to continue to work with lawmakers to pass legislation that ensures all prescribers of opioid pain medication are educated in safe prescribing practices and the identification of possible substance use disorders.

The FDA's label change came as a House panel held a hearing March 22 on opioid abuse. At the hearing, a White House official said prescription drug monitoring programs are an important tool to reduce opioid overdose deaths.

To contact the reporter on this story: Nathaniel Weixel in Washington at nweixel@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

More information about the labeling change is at http://www.fda.gov/Drugs/DrugSafety/ucm489676.htm.

More information about the FDA's regulatory approach to opioids is at http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm484714.htm.

Request Health Care on Bloomberg Law