Drug inspectors probe dexamethasone batch after adverse events at MGMGH

Trichy: Drug inspectors from the Central Drugs Standard Control Organisation (CDSCO), along with state drug control officials, inspected the Tamil Nadu Medical Services Corporation (TNMSC) warehouse in Trichy on Wednesday and Thursday following reports of serious adverse cardiac events in patients administered Dexamethasone at Mahatma Gandhi Memorial Government Hospital (MGMGH).Sources said the inspection is likely to continue for a few more days as officials examine drug stocks and related records.The probe follows a letter sent by MGMGH dean S Kumaravel to the director of medical education (DME) on May 29, seeking an analysis of a batch of Dexamethasone 8 mg injections supplied through TNMSC.In the letter, the dean flagged multiple serious adverse cardiac events suspected to be linked to a specific batch of Dexamethasone injections manufactured by Cotec HealthCare Ltd., Roorkee.According to the hospital, three patients developed severe cardiovascular complications immediately after receiving the drug intravenously. The reported adverse events included ventricular tachyarrhythmias, cardiomyopathy, severe left ventricular dysfunction, hypotension and refractory cardiogenic shock. Two of the three patients later died, including a nursing student whose death triggered protests.“The inspection by drug inspectors is a standard operating procedure after a possible adverse drug reaction is reported. It should not be seen as a conclusion on the cause of the incidents. A stop-supply order has been issued, the batch has been recalled, and samples have been sent to a laboratory for testing. The results are awaited,” a government source said.