46 Americans die every day from a prescription opioid overdose


Washington (September 12, 2018) – With more than 40 percent of all opioid overdose deaths in the United States in 2016 due to prescription opioids, Senators Edward J. Markey (D-Mass.) and Orrin Hatch (R-Utah) today introduced the Lessening Addiction By Enhancing Labeling (LABEL) Opioids Act, legislation to label prescription opioid bottles with a consistent, clear, and concise warning that opioids may cause dependence, addiction, or overdose. Specifically, the Senators’ legislation would require the Food and Drug Administration (FDA) to issue regulations providing for a warning label to be affixed directly to the opioid prescription bottle handed to the patient by the pharmacist.


Despite actions taken by many states and the federal government to limit opioid prescriptions and educate providers and consumers about the risks of opioids, approximately 50 percent of opioid dependence still originates with prescription painkillers. The label required by this legislation will directly inform patients of the potential risks of these drugs and help spur conversations between patients and their providers about appropriate use and disposal of opioids.


“The path from one bottle of pills for patients who have had their wisdom teeth removed or experienced lower back pain to addiction needs as many roadblocks as possible, and a warning label could help save lives,” said Senator Markey. “In the same way we put warning labels on cigarettes for being addictive and causing death, we need labels to caution patients about the dangers of prescription opioids. It is important that everyone who receives an opioid prescription understand the potential risks, and a sticker on an opioid pill bottle is a consistent reminder.”


“The Controlled Substances Act already requires certain warnings to be included on opioid drug labels,” said Senator Hatch. “This bill will make an important addition to those warnings to include the risk of dependence, addiction, or overdose.  These warnings will be a simple but important part of our broader response to the nation’s opioid crisis, spurring much-needed dialogue between doctors and patients about the potential harms of prescription opioids.”


A copy of the LABEL Opioids Act can be found HERE.


Utah, Arizona, and Hawaii have passed state laws requiring labeling of prescription opioids, and legislation has been introduced in New Jersey and New York. Canada has issued regulations to require opioid labeling nationally.


The legislation is endorsed by the American Public Health Association, Massachusetts Medical Society, Trust for America’s Health, the Community Anti-Drug Coalitions of America (CADCA), and the National Association of County and City Health Officials (NACCHO).