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On March 22, 2016, the U.S. Food and Drug Administration (FDA) announced enhanced warnings for immediate-release opioid pain medications. As part of a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. In addition to the boxed warning, 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.
Boxed Warning
As FDA’s press release states, prescription opioids are divided into two main categories – immediate release (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. Additionally, “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.”
FDA has also stated, “As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated using protocols developed by neonatology experts. NOWS may occur in a newborn exposed to opioid drugs for a prolonged period while in utero.”
Updated Labeling for all Opioids—FDA’s Safety Announcement states:
FDA is warning about several safety issues with the entire class of opioid pain medicines. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. The Agency is requiring changes to the labels of all opioid drugs to warn about these risks:
• Opioids can interact with antidepressants and migraine medicines to cause a serious central nervous system reaction called serotonin syndrome, in which high levels of the chemical serotonin build up in the brain and cause toxicity (see List of Serotonergic Medicines).
• Taking opioids may lead to a rare, but serious condition in which the adrenal glands do not produce adequate amounts of the hormone cortisol. Cortisol helps the body respond to stress.
• Long-term use of opioids may be associated with decreased sex hormone levels and symptoms such as reduced interest in sex, impotence, or infertility.
This announcement is part of a larger effort the Agency has outlined in its 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.
ASA is engaged in the medical community, exploring ways to address the opioid epidemic. Learn more about the AMA Task Force to Reduce Prescription Opioid Abuse.
