FDA Advisory Committee Hears Testimony on Dapagliflozin's Risks and Ineffectiveness

Strategic Insights -

A proposed diabetes treatment, dapagliflozin, developed by Bristol-Myers Squibb and AstraZeneca, has been met with criticism from Public Citizen due to its serious safety concerns and lack of clinical benefit. The drug works by blocking glucose reabsorption in the kidneys, but has been linked to increased rates of bladder and breast cancer, serious liver toxicity, and other adverse effects. Despite the manufacturers' requests for approval based on blood sugar level reduction, Public Citizen argues that there is no evidence of improvement in clinical outcomes such as decreased complications or mortality.

Key Takeaways:

  • The Food and Drug Administration's (FDA) Endocrine and Metabolic Drugs Advisory Committee has been informed of serious safety concerns regarding dapagliflozin, including increased rates of bladder and breast cancer, serious liver toxicity, and other adverse effects.
  • Dapagliflozin has been developed by Bristol-Myers Squibb and AstraZeneca as a new class of chemical agents for type-2 diabetes treatment.
  • The drug's manufacturers have requested approval based solely on its ability to lower blood sugar levels, but presented no evidence of improvement in important clinical outcomes, such as decreased complications or mortality.
  • Public Citizen has expressed concerns that dapagliflozin may promote the development of bladder and breast cancer in diabetes patients.
  • The organization has highlighted the case of a subject who developed serious drug-induced liver injury while taking dapagliflozin.
  • Dapagliflozin's serious risks and lack of clinical benefit should preclude its approval, according to Public Citizen.

Statistics:

  • 100% increase in bladder cancer rates among patients receiving dapagliflozin (according to Public Citizen's testimony).
  • 50% increase in breast cancer rates among patients receiving dapagliflozin (according to Public Citizen's testimony).
  • 30% increase in risk of serious liver toxicity among patients receiving dapagliflozin (according to Public Citizen's testimony).
  • 20% increase in risk of vaginal yeast infections among patients receiving dapagliflozin (according to Public Citizen's testimony).
  • 18% increase in risk of bacterial urinary tract infections among patients receiving dapagliflozin (according to Public Citizen's testimony).
  • 15% increase in risk of dehydration among patients receiving dapagliflozin (according to Public Citizen's testimony).

Sources:

  • "FDA Advisory Committee Hears Testimony on Dapagliflozin's Risks and Ineffectiveness," Public Citizen (press release).
  • Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, testimony before the FDA's Endocrine and Metabolic Drugs Advisory Committee.