Health experts urged to report adverse effects of anesthesia

MANILA, Philippines — Healthcare professionals have been urged to immediately report any adverse reaction related to the use of anesthesia, the Food and Drug Administration (FDA) said yesterday.

This developed after the FDA received 139 reports about the lack of efficacy associated with drug products containing bupivacaine, a potent local anesthetic.

Citing failed or incomplete spinal anesthesia, the reports were submitted by healthcare professionals from different health facilities including private and public hospitals.

The FDA cited several factors in deciding on the dosage of anesthetics to be applied such as the procedure, area to be anesthesized, individual tolerance and physical condition of the patient, among others.

To address reports on bupivacaine products available in the market, the FDA included the drug in its annual post marketing surveillance plan.

“From the annual investigation and sampling, collected bupivacaine products were tested and found conforming with the approved specifications. Specific batches reported to have failed effects were tested and found to be also conforming with the approved specifications,” the FDA said.

Based on this data, reports of failed spinal anesthesia may not be associated with the product quality, it added.

The FDA said other factors may have contributed to the occurrence of failed spinal anesthesia.

It said only trained professionals should administer spinal anesthesia, and a patient’s physical condition and medications should be considered when deciding on the dosage.