Since June 2014, the agency said it had continued to receive additional adverse event reports of diabetic ketoacidosis and ketoacidosis in patients treated with SGLT2 inhibitors.
The FDA warning also listed three combination type 2 diabetes treatments that include an SGLT2 drug as one of its two components, J&J’s Invokamet, Xigduo XR from AstraZeneca and Lilly and Boehringer’s Glyxambi.
The medicines became popular in part because in addition to controlling blood sugar levels, they led to modest weight loss and slightly lower blood pressure. Obesity is a leading cause of type 2 diabetes and some older treatments cause weight gain.
But the new FDA warning could help boost sales of alternative medicines, such as Merck & Co’s Januvia.
“Inasmuch as there will be heightened awareness of this new safety issue with the SGLT2s, it could benefit other oral diabetes drug classes such as the DPP4 inhibitors,” Bernstein analyst Tim Anderson said in a research note. “The biggest of the DPP4s, by a wide margin, is Merck’s Januvia.”
Januvia, which had sales of about $6 billion in 2014, is Merck’s top-selling product.
A series of heart safety studies, for which data recently became available, appears to have absolved the DPP4 class of concerns that had been constraining their sales.
(Reporting by Bill Berkrot- Editing by Jeffrey Benkoe and James Dalgleish)
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