Chennai: One child died, and four others were hospitalised due to paracetamol overdose after routine vaccination in 2024, the directorate of public health has said. In all five incidents, documented among 454 cases of adverse events following immunisation (AEFI), caregivers used concentrated paracetamol formulations multiple times a day, far exceeding recommended paediatric doses and resulting in liver injury, and metabolic complications.The incidents, which highlight dosage errors and misinterpretation by caregivers due to use of multiple formulations, has pushed the state to initiate a series of corrective measures, the study on paracetamol toxicity published in the state public health journal said. Paracetamol is available as liquid suspension, drops, tablets, injections, and rectal suppositories with varying concentrations, ranging between 120mg and 500mg. Doctors prescribe 10mg-15mg per kg of body weight for babies, in each dose. “In immunisation programmes, we ask field health staff to use syrup that has 125mg of paracetamol in 5ml,” said joint director of public health (immunisation) Dr K Vinay Kumar.In the first case, a three-month-old boy, who developed fever after receiving second dose of polio, pentavalent, and rotavirus vaccines, was mistakenly administered 7.5ml of paracetamol (150mg in 5ml) instead of advised 0.4ml. Next day, he exhibited tachypnea (rapid breathing) and was taken to a private hospital, where he was prescribed medication. The hospital referred the boy to a tertiary care hospital two days after vaccination. He was admitted to the paediatric ICU, placed on life support, but suffered cardiac arrest the following day and died.Four other infants –– a three-month-old girl, a four-month-old girl, and a 1.5-month-old twin –– overdosed with paracetamol, were admitted to hospitals with complications, including elevated liver enzymes, gastrointestinal bleeding and MRI changes in the brain due to toxicity. But with intensive care, they recovered. Analysis showed that the children were given 2.5ml of 150mg paracetamol in 1ml instead of 125mg paracetamol in 5ml. “This was mostly the result of misjudging dosage by field workers or miscommunication with parents. In some cases, additional doses are administered by private practitioners without verifying prior doses given to the child,” he said.The public health directorate has now initiated several corrective measures. “TN insisted on the supply of a single, uniform paracetamol formulation (125mg/5ml syrup) supplied through TN Medical Services Corporation for all immunisation programmes to prevent confusion arising from multiple formulations across different supply kits,” director of public health Dr A Somasundaram wrote in the study. Field staff were instructed to document paracetamol dosage in health records after immunisation. “We sensitised professional bodies such as the Indian Medical Association and the Indian Association of Paediatrics to advise doctors to verify prior paracetamol intake before prescribing further doses,” he added.
Join The Discussion