FDA to make opioid prescription warnings more prominentReprints
All immediate-release opioid painkillers will now feature a highlighted warning about the serious risks of misuse, abuse, addiction, overdose and death, the U.S. Food and Drug Administration said Tuesday.
The updated warning says immediate-release opioids “should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options,” such as nonsteroidal anti-inflammatory drugs, “are inadequate or not tolerated,” the FDA said in a statement.
The FDA notes that immediate-release opioids are usually used every four to six hours, while extended-release/long-acting opioids are taken once or twice a day.
The new boxed warning also cautions that chronic maternal use of opioids during pregnancy can result in opioid withdrawal syndrome for the baby, according to the statement. Meanwhile, dosing information offers instructions regarding patient monitoring and drug administration.
In addition to the warning on immediate-release opioids, the FDA says it's requiring safety labeling changes across all opioids to help inform prescribers “about the importance of balancing the serious risks of opioids with their role in managing pain.”
The updated label will include information about potentially harmful interactions with other drugs that can result in a serious central nervous system condition, according to the statement.
“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,” FDA Commissioner Dr. Robert Califf said in the statement. “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 FDA announcement is further proof of a strengthened national commitment to safeguarding the health and safety of individuals and the public,” Dr. Marcos Iglesias, vice president and medical director at Hartford Financial Services Group Inc., said in an email.