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FDA Now Requiring New Warnings For Prescription Opioids


The FDA has recently announced safety labeling changes1 for all prescription opioid drugs, including immediate-release (IR) and extended-release/long-acting (ER/LA) formulations. One of the updates will include a new warning regarding the risk of opioid-induced hyperalgesia (OIH), a condition associated with taking opioids that causes an increase in pain (hyperalgesia) or an increased sensitivity to pain (allodynia).

The FDA announced the labeling changes after they identified 46 cases of OIH through the FDA Adverse Event Reporting System. The cases most commonly involved morphine, hydromorphone, and fentanyl products; the majority involved long-term use. Cancer was the most frequent underlying condition.

Prescription opioids are powerful pain medications used to treat pain that is not eased by other treatment options. These medications can be beneficial when used appropriately, but also carry serious risks, such as misuse, addiction, and overdose. They may also cause adverse effects, such as OIH.

It isn’t clear why opioid-induced hyperalgesia (OIH) occurs or which biochemical pathways may be responsible. OIH is most often seen with long-term or high-dose opioid use.

If a patient taking opioids for chronic pain is experiencing increased pain or sensitivity to pain, their healthcare provider may not recognize OIH as a potential cause of their symptoms. Thus, the clinician may decide to increase the opioid dosage, further worsening OIH symptoms and heightening the risk of opioid overdose.

Fatal opioid overdose rates in the U.S. have climbed steadily, increasing from 47,600 reported2 overdose deaths in 2017 to more than 80,400 in 2021.

“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, MD, Director of the Center for Drug Evaluation and Research, stated in a press release.

The FDA states this update in labeling will impact the Indications and Usage, Dosage and Administration, and Warnings and Precautions sections of the prescribing information. In addition, the FDA plans to provide guidance on identifying OIH and differentiating it from opioid tolerance.

Other updates to prescription opioid labeling will include warnings against long-term use of IR opioid products unless the pain is unresponsive to other therapies, and recommends that acute pain can be treated with no more than a few days of an opioid pain medication in outpatient settings. The FDA is also urging that ER/LA products be reserved for severe or persistent pain in which other treatments do not provide adequate relief.

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