India calls for safety warnings of SGLT-2 inhibitor diabetes drugs

1 July 2019

Close on the heels of an alert raised by the US Food and Drug Administration and Health Canada regarding the safety of sodium glucose cotransporter-2 (SGLT-2) inhibitors from Johnson & Johnson (NUSE: JNJ) and Germany-based Boehringer Ingelheim, the Drug Controller General of India (DCGI) has asked drug manufacturers to carry a warning label on all new diabetes drugs, reports The Pharma Letter’s India correspondent.

J&J’s Invokana (canagliflozin) and AstraZeneca’s (LSE: AZN) Forxiga (dapagliflozin) are some of the drugs using SGLT-2 inhibitors.

A Health Ministry official said the DCGI had earlier contacted the Indian Pharmacopoeia Commission to provide information on adverse drug reactions or any signal on SGLT-2 inhibitors emphasizing the acute pancreatitis and Fournier's gangrene in Indian patients. These concerned patients under the Pharmacovigilance Program of India.

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