FDA Announces Changes to Safety Labeling Requirements for Opioid Medications

The U.S. Food and Drug Administration has announced that changes to safety labeling requirements for opioid medications are receiving final approval and implementation. These changes are part of the agency’s ongoing efforts to address the country’s opioid overdose epidemic, a crisis that has taken tens of thousands of American lives over the past several decades and is still one of the most prolific killers in the country.

The changes were first announced in April 2023 when the FDA notified application holders of Abbreviated New Drug Applications (ANDAs) and New Drug Applications of the impending arrival of saget labeling updates for extended-release/acting (ER/LA) and immediate-release (IR) opioid analgesics. The FDA also urged physicians to adopt a more patient-centered approach when they prescribe opioids for pain relief.

According to the required safety updates, drug manufacturers will have to include language regarding the increasing risk of overdose as opioid pain medicine dosages rise. Label language should also cover the fact that opioid use should not continue for an extended period unless the patient’s pain is severe and hasn’t responded to alternative treatments.

Furthermore, the safety-labeling updates recommend that physicians reserve ER/LA opioid pain medications for patients with persistent and severe pain who have not responded to alternative treatments and require daily opioid medicine for an extended period.

The updates also include a new warning about a condition called opioid-induced hyperalgesia (OIH) where opioid use either increases pain sensitivity (allodynia) or increases pain levels (hyperalgesia). This warning also provides details on how to differentiate opioid tolerance and withdrawal symptoms from OIH symptoms.

Director of the Center for Drug Evaluation and Research Patrizia Cavazzoni says that although the FDA is aware of the importance of providing acute-pain patients with continued access to opioid analgesics, the agency believes prescribers and patients should be “fully aware” of both the risks and benefits associated with opioid pain medicines. She said that the new safety-requirement updates would allow for safer opioid pain medicine use and further the FDA’s goal of reducing the risk associated with nonmedical opioid use and overdose.

The announcement expands the FDA’s efforts to implement the FDA Overdose Prevention Framework. The framework’s ultimate goal is to prevent drug overdoses and reduce deaths by preventing unnecessary initial exposure to and prolonged prescription of opioid pain medicines; encouraging harm reduction; protecting the American public from counterfeit, diverted or unapproved drugs; and pushing the development of evidence-based therapies for substance-use disorders.

For companies engaged in manufacturing generic analgesics, such as SOHM Inc. (OTC: SHMN), the new guidelines could help ensure that only those who need those medications can access them.

NOTE TO INVESTORS: The latest news and updates relating to SOHM Inc. (OTC: SHMN) are available in the company’s newsroom at https://ibn.fm/SHMN

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