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Wednesday, March 23, 2016

Black Box Warning Immediate-Release Opioids

FDA
The U.S. Food and Drug Administration (FDA) has caught a lot of flack in recent years about not doing enough to quash the prescription painkiller epidemic. That is not to say this criticism has been without merit, especially when you consider the fact that the agency approved new opioid medications in the midst of a crisis that claims over forty lives every day, such as Zohydro - a pure form of hydrocodone. While the FDA is not solely responsible for the opioid epidemic, they are in a position to stem the tide.


This week, the FDA announced that it will now require prescription opioids carry a “black box” warning label, CNN reports. The requirement will inform doctors and patients about the potential risk of: abuse, addiction, overdose and death. The label will only apply to immediate-release opioids, such OxyContin ® (oxycodone) and fentanyl; extended-release opioids which are usually taken twice daily have had black box warnings since 2013.

“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,” FDA Commissioner Robert Califf, MD said in a news 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.”

The FDA points out that 90 percent of prescription opioids are immediate-release pills. Immediate-release opioids are generally not as potent as extended-release; however, they are taken more often throughout the course of the day - generally every four to six hours. Despite being less potent, the risk of overdose and death are just as real. Extended-release opioids were given a black box warning first because they were considered to be sought after by addicts more often, according to the article. There are some concerns that the new requirement for immediate-release opioids will not be enough, considering that patients who are prescribed a drug with the disclaimer will have to go to the pharmaceutical company’s website to learn what the warning is about.

The FDA’s move is certainly important and should do some good, but will it be enough? Senator Ed Markey, of Massachusetts, a state that has been hit particularly hard by the opioid epidemic is not convinced that it will be, he believes the black box warning requirement is "too little, too late."

"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 said in a statement.

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