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Pharmaceutical industry

FDA Warns of Potential Risks with New Type 2 Diabetes Drugs

Strategic Insights

— 1 min read

The US Food and Drug Administration (FDA) has issued a warning regarding a class of type 2 diabetes drugs sold by several major pharmaceutical companies. The warning highlights the potential risk of dangerously high levels of blood acids in patients taking these medications. The oral drugs, known as SGLT2 inhibitors, work by causing blood sugar to be secreted in the urine. The FDA has identified 20 cases of diabetic ketoacidosis, ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors between March 2013 and June 2014, all of which required emergency room visits or hospitalization. The agency advises healthcare professionals to monitor patients for signs of acidosis, including ketoacidosis, and discontinue the medication if acidosis is confirmed.

Key Takeaways:

  • The FDA has warned of a potential risk of dangerously high levels of blood acids in patients taking SGLT2 inhibitors, a class of type 2 diabetes drugs.
  • 20 cases of diabetic ketoacidosis, ketoacidosis, or ketosis were identified in patients treated with SGLT2 inhibitors between March 2013 and June 2014.
  • All 20 cases required emergency room visits or hospitalization.
  • The FDA advises healthcare professionals to evaluate patients for signs of acidosis, including ketoacidosis, and discontinue SGLT2 inhibitors if acidosis is confirmed.
  • AstraZeneca's Farxiga (dapagliflozin), J&J's Invokana (canagliflozin) and Jardiance (embagliflozin) from Lilly and Boehringer are among the medications affected by the warning.
  • The signs and symptoms associated with these complications include nausea, confusion, difficulty breathing, vomiting, abdominal pain, and unusual fatigue or sleepiness.

Statistics:

  • 20 cases of diabeti ketoacidosis, ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors between March 2013 and June 2014.
  • 100% of cases required emergency room visits or hospitalization.
  • FDA Adverse Event Reporting System database.

Sources:

  • FDA website - "FDA Warns of Potential Risks with New Type 2 Diabetes Drugs"
  • "FDA Warns of Potential Risks with New Type 2 Diabetes Drugs", Domain-b.com, March 2013 - June 2014.

Note: The source material does not mention a specific date for the FDA's warning, only that it was issued on Friday. Therefore, no specific date is included in this output.

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