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India Keeps Eye On SGLT2 Inhibitors Amid Safety Signals

 
• By Anju Ghangurde

After recent safety warnings from both US FDA and Health Canada, India steps ups surveillance, but Janssen and AstraZeneca tell Pink Sheet that data indicate no major safety concerns, at least so far.

Diabetes
PATIENT DATA PERTAINING TO SGLT2 INHIBITORS ARE TO BE EXAMINED IN INDIA

In the wake of serious safety risks recently highlighted by the US FDA and Health Canada, an Indian subject expert committee (SEC), which advises the country's drug regulator on trial-related permissions and marketing clearances, has sought the examination of Indian patient data on sodium-glucose cotransporter-2 (SGLT2) inhibitors.

The US FDA had, on Aug. 29, warned that the class of type 2 diabetes medicines was linked to Fournier’s gangrene, a rare but serious infection of the genitals and area around the genitals

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