The safety of experimental diabetes drug dapagliflozin is to be analysed by America’s health watchdog, the Food and Drug Administration (FDA), following concerns about links to serious liver and cancer risks.
Dapagliflozin, produced by Bristol Myers-Squibb and AstraZeneca, was found to be effective at controlling blood glucose in patients with type 2 diabetes in recent clinical trials.
However, documents released by FDA reviewers on Friday revealed that five patients treated with the pill developed liver damage, although just one case was probably linked to the drug itself, FDA reviewers determined.
They also expressed concerns about cases of bladder and breast cancer seen in patients taking the experimental drug.
During the trial, ten people in the treatment group developed bladder cancer and nine developed breast cancer, compared to just one case of breast cancer and zero cases of bladder cancer in the control group.
A panel of FDA advisers will meet tomorrow (July 19) to discuss the drug's safety and effectiveness. Along with cancer, the FDA will also ask the panel to comment on the drug's effects on kidney and liver function, before making a final decision on its approval.
Dapagliflozin is a once-daily type 2 diabetes medication designed to allow excess sugar to be excreted with urine rather than being absorbed into the bloodstream through the kidneys.
New Diabetes Pill Raises Serious Safety Concerns
Mon, 18 Jul 2011
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