All Opioid Pain Meds to Get New Safety Warnings, FDA Says

The FDA is making several updates to prescribing information for opioid pain medications to provide guidance on safe use, according to a Drug Safety Communication, including a new warning that they can increase sensitivity to pain.

Changes to the prescribing information and labeling for immediate-release (IR) and extended-release or long-acting (EX/LA) opioids will be made to more clearly state that overdose risk increases with higher doses for all opioids.

In addition, labeling for IR opioids will state that they should not be used for extended periods, unless alternative treatment options are considered inadequate. The agency will also update its approved use for EX/LA opioids "to recommend they 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."

After a review of the available data, the FDA decided that a new warning about opioid-induced hyperalgesia (OIH), or an increased sensitivity to pain, was needed for all opioid prescriptions, and will include information describing the difference between symptoms of OIH and opioid tolerance and withdrawal.

This will also include an update to the boxed warning label for all opioid medications, which will highlight the risks of respiratory depression, as well as those associated with use of opioids with benzodiazepines or other medicines that can depress the central nervous system.

Addressing healthcare professionals, the FDA stated that they should discuss the impact of a patient's pain on their quality of life while also identifying potential causes of pain. However, if a patient's pain is more severe and alternative treatment options are inadequate, healthcare professionals should "prescribe the lowest effective dose of an IR opioid for the shortest duration of time to reduce the risks associated with these products."

They also advised that healthcare professionals should reserve increasing a patient's opioid dosage only after lower doses have proven to be insufficient. They also recommended discussing the availability of naloxone (Narcan) with all patients, and to "consider prescribing it to those at increased risk of overdose."

The new guidance comes as opioid overdose deaths involving prescription opioids have remained high, despite "a substantial overall decrease" in the number of prescriptions for these medications, the FDA said. The agency also highlighted its concerns over unused opioid tablets after surgery, which may increase the risks of accidents or misuse by children and teens.

There will also be changes to the "Warnings and Precautions" sections in the prescribing information, with required "updates to the existing patient Medication Guides to help educate patients and caregivers about these risks."

The FDA said that these changes are being made to better inform patients about the appropriate prescribing of opioids, "while also recognizing that they remain an important treatment option in appropriate situations and that undertreatment of pain (including abrupt discontinuations and forced tapering) carries its own risks."

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