The Food and Drug Administration (FDA) on Friday, Jan. 19, gathered a series of reports citing a “lack of efficacy” associated with drug products containing "bupivacaine," a prescription medication utilized as a local anesthetic or numbing medicine.

It stated that in an investigation spanning from November 2008 to October 2023, the FDA received 139 reports of “failed” or “incomplete” spinal anesthesia associated with Bupivacaine products.

Responding to these cases often involved increasing the dose, changing the anesthetic product, or resorting to general anesthesia.

The FDA disclosed that these reports were submitted by healthcare professionals from various health facilities, including both private and public hospitals.

Meanwhile, “Bupivacaine Hydrochloride,” as stated by the FDA, is intended for local or regional anesthesia during surgeries, diagnostic and therapeutic procedures, and obstetrical procedures lasting 1.5 to three hours.

The FDA clarified that the dosage of any local anesthetic, such as Bupivacaine, depends on various factors, including the procedure, the area to be anesthetized, and the patient's physical condition.

Local anesthetics function by blocking nerve impulses and their efficacy is influenced by the characteristics of the affected nerve fibers.

Moreover, to ensure the quality of Bupivacaine products on the market, the FDA has included Bupivacaine in its Annual Post-Marketing Surveillance Plan (APMSP) since 2020.

It was also noted that regular testing found that both collected Bupivacaine products and specific batches linked to failed anesthesia conformed to approved specifications, suggesting that the reported issues may not be related to product quality.

In light of this, the FDA conducted a literature review, identifying various factors that may contribute to failed spinal anesthesia.

These factors include spine abnormalities, patient resistance, lumbar interspace selection, drug dosage, unsuccessful lumbar puncture, patient positioning, and issues with intrathecal spread and/or drug failure.

Safety advisory

Related to this, the FDA strongly advises that only trained professionals with the necessary knowledge and experience should administer spinal anesthesia.

Healthcare professionals are urged to consider a patient's physical condition and concomitant medications when determining the anesthetic dose, emphasizing the use of the lowest effective dose.

As a proactive measure, healthcare professionals are encouraged to report any serious adverse reactions, lack of efficacy, or therapeutic failures associated with bupivacaine and bupivacaine-containing products to the FDA.

The agency said that this initiative aims to enhance patient safety and contribute to a comprehensive understanding of the potential factors affecting the performance of these anesthesia products.