FDA probes reports of 'failed,' 'incomplete' spinal anesthesia

The Food and Drug Administration gathered a series of reports citing a "lack of efficacy" associated with the drug products containing "Bupivacaine" due to increasing reports of "failed" or "incomplete" spinal anesthesia.

In an advisory, the FDA said the reports came from healthcare professionals from different health facilities including private and public hospitals.

From November 2008 until October 2023, the FDA said it has received a total of 139 reports of "failed" or "incomplete" spinal anesthesia.

"Based on the reports, failed spinal anesthesia were managed by increasing dose, change to anesthetic products, resorting to general anesthesia," the advisory read.

"Bupivacaine Hydrochloride" is indicated to produce local or regional anesthesia or analgesia for surgery, diagnostic, and therapeutic procedures for obstetrical procedures lasting 1.5 to 3 hours, according to the FDA.

The FDA clarified that the dosage of any local anesthetic varies with the procedure, the area to be anesthetized, and the physical condition of the patient.

Local anesthetics block the generation and the conduction of the nerve impulses, the FDA furthered.

"To ensure the quality of the registered Bupivacaine products available in the market the FDA consistently included Bupivacaine it its Annual Post Marketing Surveillance Plan (APMSP) since 2020," the FDA noted.

"From the annual investigation and sampling, collected Bupivacaine products were tested and found conforming (passed) with the approved specifications," it added.

Meanwhile, specific batches reported to have failed anesthesia were likewise tested and found to conform with the approved specifications.

Based on the data gathered by the FDA, the reports of failed spinal anesthesia may not be associated with the product quality.

*Safety advisory*

The FDA strongly advised that only trained healthcare professionals and clinicians should administer spinal anesthesia and that they should consider the patient's physical conditions and medications when deciding on the anesthetic dose.

It noted that the lowest dose required for enough anesthesia should be used.

Healthcare professionals are also urged to report any serious adverse reactions, including lack of efficacy or therapeutic failure related to "Bupivacaine" and "Bupivacaine"-containing products to the FDA.