Other safety alerts
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| Australia: SGLT2 inhibitors approved for T2DM only |
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Therapeutic Goods Administration (TGA) announces that sodium glucose co-transporter 2 (SGLT2) inhibitor products are approved for use in the management of type 2 diabetes mellitus (T2DM). They are not approved for use in type 1 diabetes (T1DM). Prescribers are reminded of the risk of diabetic ketoacidosis (DKA) with the off-label use of these medicines.
SGLT2 inhibitors improve glycaemic control in patients with T2DM by reducing renal glucose reabsorption. Through inhibition of SGLT2 in these patients, excess glucose is excreted in the urine. Due to continued local and international post-marketing reports of off-label use of SGLT2 inhibitors, the TGA is reminding health professionals that these products are approved for use in the management of T2DM only. They are not approved for use in patients with T1DM.
This applies to the SGLT2 inhibitors empagliflozin, dapagliflozin, ertugliflozin and canagliflozin marketed in Australia.
The current Product Information (PI) for these medicines has not changed, and still includes lengthy warnings regarding the increased risk of DKA with SGLT2 inhibitor use in T1DM.
In 2021, the TGA received 6 reports of off-label use with SGLT2 inhibitors in T1DM patients. Of these, 3 were associated with DKA, indicating that off-label prescribing of SGLT2 inhibitors in T1DM continues. The TGA considers that the seriousness of the risk of DKA requires an updated reminder for prescribers about the risks of off-label use of SGLT2 inhibitors in T1DM patients.
Prescribers are again reminded that SGLT2 inhibitors should be used according to the PI, and T1DM is not an approved indication for these medicines.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication/sglt2-inhibitors-approved-t2dm-only
In Hong Kong, there are 23 registered pharmaceutical products containing SGLT2 inhibitors, including empagliflozin (10 products), dapagliflozin (5 products), ertugliflozin (4 products) and canagliflozin (4 products). All products are prescription-only medicines. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction of DKA related to SGLT2 inhibitors: empagliflozin (1 case), dapagliflozin (1 case) and canagliflozin (1 case).
Related news on the risk of DKA of SGLT2 inhibitors was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 16 May 2015, with the latest update posted on 19 Mar 2020. Letters to inform local healthcare professionals were issued by the DH on 19 Mar 2020.
Currently, the package insert of locally registered pharmaceutical products containing SGLT2 inhibitors should include safety information on the risk of DKA, and the drugs should not be used for treatment of patients with T1DM. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Tuesday, Feb 15, 2022
Issued at HKT 15:30
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