The Food and Drug Administration (FDA) is making several updates to prescribing information for opioid pain medicines that it says are intended to reduce unnecessary prescribing in the wake of an opioid crisis.
“The FDA understands the important role opioid pain medicines have as a treatment option to manage pain; however, it is critically important that opioids are appropriately prescribed and patients are fully educated to reduce the risks of nonmedical use and overdose,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a press release.
A table in the guidance provides detailed information about label updates, including the following:
- The risk of overdose increases as the dose increases.
- Immediate-release opioids should not be used for an extended period unless the pain is severe enough and alternative treatments are inadequate.
- Many acute pain conditions treated in outpatient settings require no more than a few days of opioid pain medicine.
- Extended-release/long-acting opioid pain medicines should be reserved for severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine and for which alternative treatment options are inadequate.
Boxed warnings will be updated to highlight the risk of life-threatening respiratory depression and the risks associated with using opioid pain medicines with benzodiazepines or other medicines that depress the central nervous system.
The FDA also is adding a new warning about opioid-induced hyperalgesia, which can cause increased pain or sensitivity to pain.
The FDA recommends health care professionals managing a patient’s pain have a comprehensive discussion about its impact on their life and consider alternatives to opioids. If they prescribe opioids, they should follow the principles outlined in the label changes, educate patients about the risks, monitor patients for misuse/abuse and regularly reevaluate their pain management needs.
Clinicians should consider prescribing naloxone to patients at increased risk of overdose and those with children or other close contacts at risk for accidental ingestion or overdose. Last month, the FDA approved nonprescription naloxone nasal spray for over-the-counter use. It is expected to be available in drugstores, grocery stores, convenience stories, gas stations and online in late summer.
The FDA’s recent opioid efforts come as prescription opioid medicines were involved in 16,706 deaths in 2021. Data from the same year show more than 5.6 million people in the U.S. ages 12 and older reported opioid use disorder in the past year. Living in a household with opioid misuse also can put children and adolescents at higher risk of developing a substance use problem or struggling with mental health issues, research shows. Children who find unsecured opioids in the household also are at risk of accidental poisoning.
Patients should always take medications exactly as prescribed and talk to their doctor if they experience an increase in pain or pain sensitivity or have new pain, according to the FDA.
Opioids should be stored securely out of sight and reach of children. Unused opioids should be disposed of immediately. The FDA recently announced opioid pain medicine manufacturers would be required to make prepaid mail-back envelopes available at outpatient pharmacies and other dispensers.
The FDA also advises the public to seek emergency help if they or someone they are caring for experiences slow, shallow or difficult breathing, severe sleepiness or is unable to respond or wake up.
- FDA information on updates to opioid prescribing
- AAP resources to address the opioid epidemic
- Information for parents from HealthyChildren.org on opioids
- Information for parents from HealthyChildren.org on medication safety