FDA staff: J&J diabetes drug may pose heart risk
Federal drug reviewers think Johnson & Johnson's experimental diabetes drug might bring heart risks because it raised cholesterol levels in patient testing.
In documents just released, Food and Drug Administration staff experts conclude studies showed canagliflozin (kann-AH'glih-floh-zin) slightly increased heart complications and risk of a urinary tract infection. That's because the pill works by boosting blood sugar excretion via urine.
The studies didn't find other serious problems, such as weakening of bones, damage to the liver or kidneys, or various cancers.
If the FDA approves the New Brunswick, N.J., company's drug, it would be the first in a new class of Type 2 diabetes medicines, called SGLT2 inhibitors.
Outside advisers to the FDA will review the data during a meeting Thursday and recommend whether the agency should approve canagliflozin.
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