The Food and Drug Administration announced Tuesday plans to add a new boxed warning — the most serious type — to all immediate-release opioid painkillers, including combination pills containing oxycodone and non-prescription drug ingredients. Those drugs, sold as Vicodin and many generic brands, are consistently among the most prescribed drugs in the U.S., accounting for more than 135 million prescriptions in 2012.
The long-awaited change comes roughly three years after the FDA added bolder warnings to long-acting opioid drugs like OxyContin, which slowly release their doses over 12 hours or more. The labeling switch means both drug formulations will now carry similar information about the risks of addiction, abuse, overdose and death.
“Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products,” said FDA Commissioner Dr. Robert Califf, in a statement.
Critics of the FDA’s approach to regulating opioids, including the group Physicians for Responsible Opioid Prescribing, have for years petitioned the agency to bolster warnings on immediate-release opioids.
Opioids are a class of powerful and highly-addictive drugs that include both prescription drugs like codeine and hydrocodone, as well as illegal narcotics, like heroin. Prescription opioids accounted for over $9 billion in sales last year for companies like Teva Pharmaceuticals, Johnson & Johnson’s Janssen Pharmaceutical, Purdue Pharma and others.
Deaths linked to misuse and abuse of prescription opioids climbed to 19,000 in 2014, the highest figure on record, according to the Centers for Disease Control and Prevention. Heroin and opioid painkillers combined caused 28,650 fatal overdoses. Many prescription opioid abusers eventually switch to heroin because it sells for up to five times less than pills or tablets.
Government officials have already tried a variety of approaches to tackling painkiller abuse in recent years. The FDA previously restricted drugs like Vicodin to limit refills and who can prescribe them. States like Florida and New York have cracked down on “pill mills” using databases to monitor what doctors are prescribing. Earlier this month, Massachusetts signed into law a seven-day limit on first-time prescriptions for opioids — the first of its kind in the nation.
The FDA announcement comes less than a week after the CDC released the first-ever national prescribing guidelines for using opioids. The agency said primary care doctors should only turn to opioids after considering physical therapy, over-the-counter medications, counseling and other methods for treating chronic pain. When prescribing opioids for short-term pain, the agency said doctors should prescribe a 3-day supply, whenever possible.
The Associated Press contributed to this article.