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    • Hypoglycaemia, Mental...

    Hypoglycaemia, Mental Health Side Effects: Label side-effect warnings of Fluoroquinolone, DCGI tells Drugmakers

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2018-10-26T11:04:23+05:30  |  Updated On 16 Aug 2021 3:04 PM IST
    Fluoroquinolones are antibiotics used to treat respiratory and urinary tract infections. These medicines include ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfioxacin, ofloxacin etc, the order said.

    New Delhi: Central drug regulator DGCI has asked all drugmakers manufacturing the 'fluoroquinolones' antibiotic to label it with a cautionary message about its side-effects of potentially causing low blood sugar and mental health-related problems. The warnings need to be carried on the package as well as promotional literature of the drug and follows safety issues reported by the US Food and Drug Administration (USFDA) for this drug.

    In an order, the Drug Controller General of India (DCGI) S Eswara Reddy has directed all state drug controllers to ensure that the label of the product carries a cautionary message that "this drug may cause low blood sugar and mental health-related side-effects".

    Besides, the package-insert and promotional literature would also need to mention a warning: "The drug may cause low blood sugar and mental health-related side effects. Low blood sugar levels, also called hypoglycaemia, can lead to coma. The mental health side effects are more prominent and more consistent across the systemic fluoroquinolone drug class".

    Fluoroquinolones are antibiotics used to treat respiratory and urinary tract infections. These medicines include ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfioxacin, ofloxacin etc, the order said.

    The order dated October 23 has also suggested mentioning mental health side-effects like disturbances in attention, disorientation, agitation, nervousness, memory impairment and delirium across all the fluoroquinolones.

    All state regulators have been asked to revert with their respective action is taken reports at the earliest.

    Reddy said the USFDA has warned that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.

    "In light of the safety issues reported by the USFDA, the matter was examined by the Central Drugs Standard Control Organization Company in consultation with the Subject Expert Committee (Antimicrobial and antiviral) in its meeting held on August 7," he said.

    Read Also: Stronger Warning for fluoroquinolone antibiotics added by FDA
    AntimicrobialCDSCOCentral Drug RegulatorCentral Drugs Standard Control OrganizationCiprofloxacinDGCIDrug Controller General of IndiaEswara ReddyfluoroquinolonesGemifloxacinlevofloxacinlow blood sugarmoxifloxacinnorfioxacinOfloxacinUS Food and Drug AdministrationUSFDA
    Source : PTI

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    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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