Central Drugs Standard Control Organisation directs Fludrocortisone manufacturers to add Hypokalaemia as adverse drug reaction

The Central Drugs Standard Control Organisation has directed manufacturers of Fludrocortisone formulations to add hypokalaemia, or low blood potassium levels, as an adverse drug reaction in the prescribing information leaflet and promotional literature. The direction follows safety signal assessment by the Pharmacovigilance Programme of India and expert review.

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