Background and Objective As of December 2017, 20 diabetic ketosis (DK)/diabetic ketoacidosis (DKA) cases associated with sodium–glucose co-transporter 2 inhibitors (SGLT2i) had been reported to the Health Sciences Authority (HSA), Singapore. We aimed to provide a detailed analysis of the profile of these cases. Methods As part of the emerging safety issue monitoring, the HSA followed up on SGLT2i-associated DK/DKA cases with the reporters to obtain the missing and/or supplementary information. Descriptive statistics were employed to summarise the data collected, while the Mann–Whitney test was employed to evaluate the differences between typical and euglycaemic DKA cases as well as between genders. Results All cases led to hospitalisation but were non-fatal. Where reported, the majority (71–85%) of DK/DKA cases occurred within 180 days of SGLT2i therapy initiation and involved female patients and/or patients with long-standing type 2 diabetes mellitus (T2DM). Apart from the difference in blood glucose levels, no differences in the profile between the typical and euglycaemic DKA cases were noted. Known precipitating factors were identified in all cases. Acute illnesses, particularly infections and abscesses, were the most commonly reported precipitating factors, followed by insulin dose reduction/cessation. Conclusions Based on the profile of the reported cases, it is imperative to maintain clinical vigilance for DK/DKA, especially during the first 6 months of SGLT2i treatment and more so in female patients and/or patients with long-standing T2DM. Prompt evaluation and management of underlying precipitating factors is also important to assess and mitigate the risk of developing DK/DKA during treatment with SGLT2i.

Background: Effective benefit–risk communication to healthcare professionals plays a vital role in promoting the rational use of medicinal products. The Health Sciences Authority (HSA) of Singapore has implemented Physician Educational Materials (PEMs) and Patient Medication Guides (PMGs) as educational materials to support informed decision-making. To evaluate their effectiveness as a safety communication tool, we sought to understand prescribers’ experiences and preferences with these materials. Methods: Invitations to an online survey were emailed to 387 healthcare professionals who had recently purchased the 22 medicinal products with requirements for educational materials in Singapore (“Purchasers”). The survey scope included their experiences with the receipt and usage of the materials, and their preferences towards the types of content and distribution channels for these materials. Results: The survey invitation reached 367 purchasers, of which 89 (24%) responded, including 66 who indicated that they had prescribed the surveyed products (“Prescribers”). Although only 47% of prescribers recalled receiving the educational materials, the majority who had used them found them useful in their clinical practice. However, the PMG was used less frequently than the PEM (59% vs 96%), and there was a mismatch between current and preferred distribution methods (mostly hard copies vs electronic copies). Conclusions: Prescribers who had received educational materials generally perceived them as being useful in raising awareness on treatment-associated safety concerns. The publication of educational materials on the HSA website and encouraging more routine distribution of PMGs by prescribers may improve their accessibility and facilitate safety communication on medicinal products to healthcare professionals and patients.

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