FDA Will Finally Require Black Box Warning Labels On Opioid Prescription Painkillers

By John Lavitt 03/24/16

The new warning labels will be added to nearly 200 branded and generic opioids, including commonly abused painkillers like OxyContin and Vicodin.

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FDA Will Finally Require Black Box Warning Labels On Opioid Prescription Painkillers
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After years of inaction in the wake of the growing opioid epidemic, the Food and Drug Administration (FDA) is now going to require pharmaceutical companies to place black box warning labels on immediate-release (IR) opioid prescription medication. On Tuesday, the FDA announced that IR painkillers, which have to be taken every four to six hours, will now be required to come with a label that warns against the risk of abuse, addiction, overdose and even death.

The new warning labels will be added to nearly 200 branded and generic IR opioid painkillers, including the most commonly abused drugs like OxyContin and Vicodin. According to the Centers for Disease Control and Prevention (CDC), close to 25,000 people died from reported prescription opioid overdoses in 2014. Given that more than 15,000 prescription opioid overdose deaths occurred every year from 2007 to 2014, requiring black box labeling—the strictest kind of warning label required by the FDA—on these drugs is long overdue.

Dr. Robert Califf, the FDA commissioner, explained why the agency is finally taking action. "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," he said in a press release. "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."

For the first time, the new labeling on these drugs will be required to provide detailed information regarding patient monitoring and drug administration, including information about dosage changes during therapy, potentially harmful side effects caused by interactions with other drugs, and the possibility of decreasing in sex hormone levels. The label will also warn against stopping treatment abruptly in physically dependent patients.

The black box warning labels will also warn pregnant women that continuous painkiller use can result in their babies suffering from Neonatal Opioid Withdrawal Syndrome (NOWS), which can be life-threatening if not recognized and treated. A simple Google search will reveal that the rate of drug-affected newborn babies is on the rise in many U.S. states, as drug abuse rates rise as well.

“We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with IR opioid products,” said Dr. Douglas Throckmorton, deputy center director of regulatory programs in the FDA’s Center for Drug Evaluation and Research. “Today, we have taken an important next step in clarifying and making more prominent the known risks of IR opioid medications.”

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Growing up in Manhattan as a stutterer, John Lavitt discovered that writing was the best way to express himself when the words would not come. After graduating with honors from Brown University, he lived on the Greek island of Patmos, studying with his mentor, the late American poet Robert Lax. As a writer, John’s published work includes three articles in Chicken Soup For The Soul volumes and poems in multiple poetry journals and compilations. Active in recovery, John has been the Treatment Professional News Editor for The Fix. Since 2015, he has published over 500 articles on the addiction and recovery news website. Today, he lives in Los Angeles, trying his best to be happy and creative. Find John on Facebook, Twitter, and LinkedIn.