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FDA sees heart risk in J&J drug

Johnson & Johnson’s experimental diabetes drug might bring minor heart risks because it raised cholesterol levels in patient testing, according to federal drug reviewers.

In documents released Tuesday, Food and Drug Administration staff experts conclude studies showed J&J’s canagliflozin raised levels of LDL, or bad cholesterol, and slightly increased risk of heart attack, stroke, or death, compared to two other types of diabetes medications.

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Studies also showed the pill increased risks of urinary tract infections and fungal infections in the genital area. That’s because canagliflozin works by boosting blood sugar excretion via urine, and germs thrive on that sugar.

The studies didn’t find other serious problems.

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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