FDA reviewers: Diabetes drug may pose heart risk
January 8th, 2013 at 5:36 pm
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.
Data from nine large patient 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, such as weakening of bones, damage to the liver or kidneys, or various cancers.
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