New warnings about addictive prescription.
The U.S. Food and Drug Administration (FDA) announced Tuesday new safety labeling changes for immediate-release (IR) opioid pain medications. From here on out, there must be warnings on prescription medications about the risks of addiction, abuse, misuse, overdose and deaths. The FDA hopes that this change will lessen the addiction epidemic while still providing relief to patients with pain.
Immediate-release medications are a type of opioid prescription medication that is taken every 4 to 6 hours for pain. These medications are only prescribed when the pain cannot be treated with other alternatives. Some common types of IR medications are Oxycodone, hydrocodone, and morphine.
Robert Cardiff, M.D., FDA commissioner indicated at the time of the release, “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. Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”
The new labels will also be required to include more precise instructions about monitoring patients and their dosages. It will contain a warning to not suddenly stop treatment in patients who are dependent on addictive prescriptions as well.