On 25 March 2019, in response to an alert raised by US FDA and Health Canada in regard to the safety of Sodium- Glucose Cotransporter -2 (SGLT-2) inhibitors of Johnson & Johnson and Boehringer Ingelheim India, the Drug Controller General of India (DCGI) has asked Indian Pharmacopoeia Commission (IPC) to provide information on Adverse Drug Reactions (ADRs) or any signal on SGLT-2 inhibitors emphasizing the acute pancreatitis and Fournier's gangrene in Indian patients received under Pharmacovigilance Programme of India (PvPI). Further to this response, '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.
The basis of Safety Warnings:
Health Canada: It has published Summary safety Review of SGLT2 inhibitors by assessing the potential risk of inflammation of the pancreas on 20.07.2018. 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 29.08.2018and 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.
I.e. Sodium-Glucose Cotransporter -2 (SGLT-2) inhibitors.
Further Subject expert committee has recommended certain points based on these findings:
- Data should be obtained from PvPI regarding any new signal based on SGLT-2 inhibitors based on above two conditions in Indian patients.
- CDSCO should monitor any further new findings with SGLT-2 inhibitors.1 In response to above discussion, PvPI was requested to provide the information about the details ADRs and any signal on SGLT-2 inhibitors emphasizing the acute pancreatic and Fournier's gangrene in Indian Patients.
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.
Conclusion:
The latest finding published by Health Canada and US FDA in concern of new adverse events associated with Sodium-Glucose Cotransporter -2 (SGLT-2) inhibitors (pancreatic and genitals infection) had made DCGI to further the information on Adverse Drug Reactions (ADRs) or any signal on SGLT-2 inhibitors from PVPI. Further, CDSCO has published a safety warning for all the manufacturers to be printed at the label of these class of drugs.
Footnote
1 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI2Mg==the
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