SEC Committee Recommends Metformin SR for Gestational Diabetes; Final Approval Pending
The Endocrinology & Metabolism Subject Experts Committee (SEC), under the Central Drugs Standard Control Organization (CDSCO), recently reviewed the use of Metformin Hydrochloride Sustained-Release (SR) Tablets for the management of gestational diabetes. Following the review, the SEC has recommended the consideration of Metformin SR 500 mg & Metformin SR 1000 mg for use during pregnancy, at the treating physician's discretion, as an adjunct or alternative to insulin therapy.
Metformin is one of the most widely used first-line agent for the management of type 2 diabetes, Prediabetes and is also approved for the treatment of Polycystic Ovary Syndrome (PCOS) with established insulin resistance. Its applicability and safety during pregnancy and the peri-conceptional period were recently evaluated by the Subject Expert Committee (SEC) in the presence of gynecologists and neonatalogists as special invitees. Its use in gestational diabetes is currently under review by regulatory authority.
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