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A revelation that a university hospital in Tokyo has been habitually administering a powerful sedative banned for use on children placed on ventilators has raised safety questions on the reportedly widespread practice of off-label use of drugs. Doctors can and do, at their own discretion, use drugs on patients in ways forbidden by drug manufacturers when it’s deemed a matter of medical necessity. The question is whether priority is given to the benefit and safety of patients or to the convenience of doctors.

A 2-year-old boy who had an operation to remove lymphangioma at Tokyo Women’s Medical University Hospital in February died three days after he was given propofol, an anesthesia-inducing agent while he was on a ventilator at an intensive care unit of the hospital in Shinjuku Ward. Following a complaint from the boy’s parents and a police investigation, the hospital admitted that the boy’s death had been caused by improper use of the sedative. The hospital also disclosed that its doctors had administered propofol to 63 patients aged 14 or younger who had been on ventilators over the past five years and that 12 of the patients died. But it denied any link between their deaths and the use of the drug.

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