With Opioid Addiction On The Rise, FDA Issues New Guidelines For Labeling Painkillers

CREDIT: AP Photo, Toby Talbot

OxyContin pills at a pharmacy in Montpelier, Vt.

Faced with an all-time national high of opioid-induced overdoses, the Food and Drug Administration (FDA) rolled out strict new guidelines for labeling addictive painkillers Tuesday afternoon. These new rules will require fast-acting opioid-based drugs, like OxyContin, Demerol, Percocet, and Vicodin, to come with a new warning about the serious risks of abuse, addiction, overdose, and deaths linked to the painkiller.

These quick-release forms of opioid drugs represent about 90 percent of painkiller products on the market. And while they are meant to diffuse temporary pain, like a broken bone, wisdom tooth removal, or surgery, these opioids have quickly become the nation’s top drug of choice for people struggling with addiction.

“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, FDA commissioner, in a press release. Califf said the new regulations are just a part of the FDA’s “comprehensive action plan” to attack the crisis in 2016.

This sweeping update is just one of the new ways federal organizations and Congress are expressing their interest in reversing drug addiction. The FDA’s announcement comes a week after the Centers for Disease Control and Prevention (CDC) released new voluntary guidelines that suggest primary care physicians limit the dosage of opioid painkillers for patients — or offer alternative treatments for chronic pain before prescribing. Days before, the U.S. Senate swiftly passed a bipartisan bill that would fund addiction prevention and recovery programs.

The new FDA labels will also include the dangers of using these types of drugs while pregnant. Over the past decade, more than 130,000 newborns have entered the world addicted to drugs and facing a painful withdrawal process. Regardless, many pregnant women have been prescribed opioid painkillers.

But will updating the warning labels on addictive drugs be enough? Some legislators don’t think so.

Shortly after the FDA’s announcement, Senator Ed Markey (D-MA) told the New York Times that the changes “have done little to prevent prescription drug opioid addiction,” and that “it has taken the F.D.A. far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone.”

This action failed to address a petition signed by 41 city and state health department heads in February, which asked for labeling that warned users of the risk of mixing a painkiller with another type of drug. In its press release, the FDA said it is currently reviewing this risk.