In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications.
Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death.
Today’s actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications.
The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.
The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications.
This is part of the agency’s overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.
Opioid analgesics are powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine, among others.
Prescription opioids are divided into two main categories – IR products, usually intended for use every four to six hours; and extended-release/long-acting (ER/LA) products, which are primarily intended to be taken once or twice a day, depending on the individual product and patient.
Certain opioids, such as methadone and buprenorphine, are also used as a form of treatment for opioid addiction, and in combination with behavioral therapy and counseling, are known as medication-assisted treatment, or MAT.
The updated indication clarifies that because of these risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., non-opioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated.
The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient.
Source: U.S. Food and Drug Administration, USA.