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NEW DELHI: A commonly used spinal anaesthesia drug has come under scrutiny after the Indian Society of Anaesthesiologists (ISA) advised doctors across the country to immediately stop using Themis-manufactured bupivacaine following reports of serious adverse events.In an urgent advisory issued on Monday, the ISA asked anaesthesiologists nationwide not to use bupivacaine manufactured by Themis for spinal anaesthesia or any other purpose until further notice, saying the precautionary measure had been taken in the interest of patient safety while investigations are underway.Bupivacaine is among the most commonly used local anaesthetics for spinal and epidural anaesthesia during surgeries. The ISA said the advisory followed reports of serious adverse events linked to the Themis-manufactured drug, but did not disclose the number or nature of the events. Investigations are continuing.Hospitals have also been advised to identify and segregate existing stocks of the drug, withdraw them from clinical use and switch to alternative approved brands for spinal anaesthesia procedures.A separate caution notice issued by the ISA’s Hyderabad Metro City Branch directed consultants, resident doctors, anaesthesia technicians and operation theatre personnel to immediately suspend the use of Themis Bupivacaine for spinal anaesthesia. It said no ampoules of the product should be used for neuraxial administration until an official clearance is issued, and any inadvertent use must be reported immediately to the head of the department.”This is a precautionary advisory issued in the interest of patient safety. Reports of serious adverse events have been received from multiple hospitals, and until the investigation is completed, we have advised doctors to stop using the product,” said Dr Sherry Mathews, president of the Hyderabad Metro City Branch of the Indian Society of Anaesthesiologists.
