Medmonitor

The FDA will be requiring several updates to the prescribing information for all opioid pain medications. All opioid pain medications will note that the risk of overdose increases as the dose increases, as well as a new warning about opioid-induced hyperalgesia (OIH) with information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal. Boxed warnings across all opioids will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS). Other changes are also being required to several sections of the prescribing information, including to the Indications and Usage, Dosage and Administration, and Warnings and Precautions sections. Additional, specific updates will also be made respectively to immediate-release opioids and extended-release/long-acting opioids.

Teva Pharmaceuticals has voluntarily recalled specific lots of various strengths of fentanyl buccal tablets CII at the consumer level due to a labeling error. This recall has been initiated because safety updates were omitted in the Product Insert/Medication Guide (MG) that are provided with these recalled lots. The main safety concern is a potential for incomplete information needed by health care providers and patients regarding safe use of the product. Not following, or not being aware of, the omitted safety updates in the Product Insert/Medication Guide (MG) could lead to life-threatening adverse events. Thirteen lots of this medication are affected by the recall.

The FDA approved Narcan (naloxone hydrochloride) 4mg nasal spray for over-the-counter (OTC) use – the first naloxone product approved for use without a prescription. Naloxone rapidly reverses the effects of opioids and is the standard treatment for opioid overdose. As opioid pain medications are commonly used in workers’ comp and come with risk of overdose even when used properly, this approval makes this life-saving drug more accessible for injured worker patients. The approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed.

The FDA will soon require opioid manufacturers to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients. The FDA issued notice to all opioid manufacturers that they are required to submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days of the date of notification. The agency anticipates approval of the modified REMS in 2024. When implemented, outpatient pharmacies and other dispensers will have the option to order prepaid mail-back envelopes from opioid analgesic manufacturers, which they may then provide to patients prescribed opioid analgesics

Bryant Ranch Prepack Inc. is voluntarily recalling one lot of morphine sulfate 30 mg Extended-Release tablets and one lot of morphine sulfate 60 mg Extended-Release tablets, as the labels for these two products were mixed-up. Morphine sulfate is an opioid product for the management of severe pain. Patients prescribed the 30 mg dose who receive the 60 mg dose could be at risk for overdose and death. Patients prescribed the 60 mg dose who receive the 30 mg dose may experience withdrawal and untreated pain if the dose given is too low.