FDA to require warning labels for painkillers
Gov't agency expects to finalize the new labeling requirements by the end of the year
In the United States, a person dies every 19 minutes from a prescription drug overdose. Many of those deaths are attributed to a family of painkillers known as opioids.
In an effort to reduce abuse, the Food and Drug Administration announced on Tuesday that it "is invoking its authority to require safety labeling changes and post-market studies to combat the crisis of misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities," according to a press release.
The label changes are meant for extended-release or long-acting opioids like oxycodone and hydrocodone, among others.
FDA Commissioner Dr. Margaret Hamburg told reporters: "These drugs are at the heart of the abuse epidemic. But we must recognize the medical use they have."
Currently, the labels on the drugs say they are for "the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time."
To discourage over-use and misuse of the drugs, the new labels will say the drugs should be used only when "alternative treatment options are inadequate." While the label changes are something physicians should be aware of, the FDA said it hopes this will result in a larger conversation about pain management between patients and doctors.
The FDA expects to finalize the new labeling requirements by the end of this year.