On March 22, 2016, the FDA announced that a labeling change will be required class-wide for immediate-release (IR) opioid medications prescribed for pain. According to their announcement, this change is a direct result of the FDA’s “continuing effort to educate prescribers and patients about the potential risks related to opioid use.”
Opioid addiction and misuse are serious problems in the United States. The CDC reported that there were more than 28,000 deaths from opioids in 2014 alone, and half of those involved a prescription opioid.
“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 issues and abuse of prescription opioids,” said FDA commissioner Dr. Robert Califf in the FDA news release.
We’ve said the word a lot, but for those who may not know, what are “opioids” exactly?
Opioids are painkillers and powerful medications. You’re probably more familiar with some of their more common names: oxycodone, hydrocodone, methadone, buprenorphine, morphine and heroine (yes, heroine started out in 1898 as a medication before it was proven too addictive and dangerous and became extremely restricted and banned in the 1930s).
This new labeling obligation for IR opioids follows a similar class-wide labeling change requirement the FDA issued in 2013 for extended-release/long-acting opioid products. That 2013 change required “modifications to the products’ indications, limitations of use, and warnings, including boxed warnings to more effectively communicate to prescribers the serious risks associated with these drugs.” The new labeling regulations for IR opioids follow the same line.
For more information on this labeling change and the government’s commitment to combatting this epidemic, take a look at the Health and Human Services news release which outlines their initiative to reduce opioid and heroin overdose, death and dependence.