Fludrocortisone 0.2 mg Study Rejected by CDSCO Panel Over Potential Adverse Effects
New Delhi: Noting the possible risk of expected adverse effects in healthy subjects, the Subject Expert Committee (SEC), functioning under the Central Drug Standard Control Organization (CDSCO), has declined to recommend a proposed clinical study by Advity Research Private Limited for Fludrocortisone Tablets USP 0.2 mg.
This came after the firm presented the protocol along with published literature of Fludrocortisone Tablet USP 0.2 mg, in light of the earlier SEC recommendation dated 07.08.25.
Fludrocortisone is a mineralocorticoid used to treat adrenocortical insufficiency and salt-losing adrenogenital syndrome.
The main endogenous mineralocorticoid, aldosterone, is produced in the zona glomerulosa of the adrenal cortex—it acts on mineralocorticoid receptors in the kidneys to increase sodium reabsorption and potassium excretion, which in turn helps to regulate plasma electrolyte composition and blood pressure. In conditions of adrenal insufficiency, such as Addison’s disease, aldosterone is not produced (or is produced in insufficient quantities) and must be replaced by exogenous mineralocorticoids such as fludrocortisone.
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Fludrocortisone binding to mineralocorticoid receptors causes alterations to DNA transcription and translation of proteins that result in an increased density of sodium channels on the apical side of renal tubule cells and an increased density of Na+-K+-ATPase on the basolateral side. These increases in receptor density result in increased plasma sodium concentrations, and thus increased blood pressure, as well as a decreased plasma potassium concentration. Fludrocortisone may also exert a direct effect on plasma sodium levels via action at the Na+-H+ exchanger found in the apical membrane of renal tubule cells.
At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the protocol along with published literature of Fludrocortisone Tablet USP 0.2 mg presented by Advity Research Private Limited.
After detailed deliberation, the committee did not recommend the study due to the possible risk of expected adverse effects of Fludrocortisone Tablet USP 0.2 mg in healthy subjects.
