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Commonly used antibiotic in India under USFDA lens

Fluoroquinolone, a commonly used antibiotic in India for the treatment of a range of bacterial infection, has come under the US Food and Drug Administration (USFDA) scanner for its effect on mental health and for causing low blood sugar adverse reactions, including coma.Through its review of adverse event reports and case reports published in medical literature, the US regulator has found instances of hypoglycaemic coma due to blood sugar disturbances in users of fluoroquinolones. 64953989 It has ordered safety labelling changes for the antibiotics to strengthen the warnings about the risks and make them more consistent across the labelling for all fluoroquinolones taken by mouth or given by injection.The US FDA warning has also alerted doctors in India. “We will be watchful while prescribing it and will issue adequate instructions to patients,” says Dr Anoop Misra, chairman, Fortis C-Doc. “The use of fluoroquinolones has a place in the treatment of serious bacterial infections and they should remain available as a therapeutic option,” said Edward Cox, MD, director of the office of antimicrobial products in the FDA’s Center for Drug Evaluation and Research.

Source: ET

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