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28 Mar 2019

DCGI making it mandatory to include warning in the package insert and promotional literature SGLT2 inhibitor drugs

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SGLT2 inhibitors

SGLT2 inhibitors, medicines that lower blood sugar by causing kidneys to remove sugar from the body through urine, include drugs such as canagliflozin, dapagliflozin, empagliflozin and ertugliflozin.

Class

Anti-diabetes medications

All the manufacturer of SGLT2 inhibitors, has to include new warning on their labels after a directive from the Drug Controller General of India (DGCI) over potential risk of acute pancreas inflammation and a rare but serious genital infection. 

The national drug regulator’s action follows safety warnings from Health Canada and the US Food and Drug Administration. Last year, Health Canada published a summary safety review of SGLT2 inhibitors that reported a potential link between drug use and pancreatitis. And this year, the US FDA has issued the warning about serious genital infections. In the basis of global safety issues, the National Co-ordination Centre of Pharmacovigilance Programme of India (NCC-PvPI) had provided individual case safety reports regarding adverse drug reactions on SGLT-2 inhibitors. After reviewing these reports, the CDSCO expert panel had also recommended that data should be obtained from the NCC-PvPI regarding any signals on the SGLT2 inhibitors from Indian patients. The drug inspectors in all states are also asked to keep a close eye on the matter.

Download CDSCO circular copy

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