FDA Adds Black Box Warning To The Most Common Prescription Painkillers

In the face of America's growing opioid addiction epidemic, the U.S. Food and Drug Administration (FDA) has just taken a step to make us more aware of the potential hazards of taking these drugs. The agency will now require all immediate-release formulas of opioid painkillers to carry the agency's most cautious label, known as a "black box" warning. The drugs, including oxycodone, hydrocodone, and morphine, are among the most commonly prescribed drugs. And the "black box" is the strongest type of FDA warning for a drug to receive. In particular, this labeling for opioids will warn of the potential for addiction, abuse, and overdose — even when taking the drugs to manage pain. This action also builds on previous warnings, which were given to extended-release formulas in 2013. Addiction to opioids (including prescription medications and heroin) has been a problem in the country for decades. But it's a problem that's increasingly affecting women. Both limiting access to these painkillers and improving access to the overdose-reversing drug naloxone are important parts of efforts to curb the epidemic. “Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products," said FDA commissioner Robert Califf, MD, in a press release, "and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.” So stay tuned.