A consumer advocacy is urging the Food and Drug Administration to heighten warnings about a widely prescribed group of diabetes drugs known as SGLT-2 inhibitors, due to hundreds of cases of a potentially fatal reaction among people with type 1 diabetes, even though the medicines are not approved for those patients.

In a citizen’s petition being filed with the agency on Wednesday, Public Citizen argued that a “black box” warning, the most serious safety warning found in prescription drug labeling, should note SGLT-2 inhibitors can cause ketoacidosis. This is a serious complication of diabetes that occurs when the body produces high levels of blood acids called ketones and develops when the body fails to produce enough insulin.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!

GET STARTED

What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
Sign up to receive a free weekly opinions recap from our community of experts.
Privacy Policy