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Diabetic drug warning

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Dr KK Aggarwal    18 April 2019

SGLT2 warning

On 25 March 2019, in response to an alert raised by US FDA to the safety of Sodium- Glucose Cotransporter -2 (SGLT-2) inhibitors the Drug Controller General of India has asked Indian Pharmacopoeia Commission  to provide information on Adverse Drug Reactions  emphasizing the acute pancreatitis and Fourniers gangrene in Indian patients received under Pharmacovigilance Programme of India.

Central Drugs Standard Control Organization has published a safety warning for all the manufactures dealing with manufacturing of Sodium-Glucose Cotransporter -2 (SGLT-2) inhibitors class of drug including canagliflozin, dapagliflozin and empagliflozin.

Health Canada: Safety Review of SGLT2 inhibitors: the review further concluded that there may be a link between the use of SGLT2 inhibitor and acute pancreatic.

USFDA: The safety announcement was given on 29.08.2018 and warnings were given that cases of rare but serious infection of genitals and areas around the genitals have been reported with this class of type 2 diabetes.

Warning:- Cases of rare but serious infection of the genitals and area around the genitals have been reported with this class of type 2 diabetes medicines I.e. Sodium-Glucose Cotransporter -2 (SGLT-2) inhibitors.

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI2Mg==the

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