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WASHINGTON (AP) — Federal health regulators have concerns about
bladder and breast cancer seen in patients taking an experimental
diabetes pill from Bristol-Myers Squibb and AstraZeneca.
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The Food and Drug Administration said in an online review Friday
that there were more cases of cancer among patients taking the
company’s drug than those taking a dummy pill. It was not clear
whether the higher rate was caused by a statistical fluke or the
drug itself.
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A panel of FDA advisers meets next Tuesday 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. FDA will make the final decision on the drug’s
approval.
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Dapagliflozin is a once-a-day pill designed to help type 2 diabetes
patients eliminate excess sugar in their urine. It differs from
older drugs that decrease the amount of sugar absorbed from food.
If approved, Bristol and AstraZeneca’s drug would be a new option
for diabetics, who must often rotate through several medications to
control their disease.
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But FDA scientists have concerns about the drug’s safety,
particularly after higher rates of bladder and breast cancer that
were reported in company trials. The companies reported 10 bladder
cancers among patients taking the drug compared with none on those
taking a dummy pill. There were nine breast cancers compared with
one in the control group. While neither study was designed to
measure cancer risk, FDA scientists noted that the number of
bladder cancers “significantly exceeded the rates expected” in
diabetes patients.
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Bristol-Myers and AstraZeneca have touted the drug as the first in
a new class of drugs to address the nation’s growing diabetes
epidemic, which affects more than 25 million people.
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In two-year studies of the drug, patients taking dapagliflozin had
lower blood sugar levels and lost more weight than patients taking
an older diabetes drug, Glucotrol.
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But in its final conclusion the FDA said those results must be
weighed against various safety concerns, including cancer, livery
injury and bladder infection.
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People with type 2 diabetes are unable to properly break down
carbohydrates, either because their bodies do not produce enough
insulin or because of resistance to insulin. They are at higher
risk for heart attacks, kidney problems, blindness and other
serious complications.
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Diabetics often require multiple drugs with different mechanisms of
action to control their blood sugar levels.
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New York-based Bristol-Myers Squibb Co. and London-based
AstraZeneca PLC already co-market the diabetes drug Onglyza, which
increases insulin production while reducing glucose
production.
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