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Johnson & Johnson’s New Diabetes Drugs May Pose Heart Risks, FDA Staff Says

Filed January 9th, 2013 admin

The U.S. Food and Drug Administration (FDA) has expressed concerns that Johnson & Johnson’s (J&J) new diabetes drug Invokana (canagliflozin) may pose heart risks. The FDA’s fears are based on clinical trials that found the drug raised the level of bad cholesterol in patients who took the drug.

Diabetes affects about 370 million people across the globe, and about 90 percent of those cases are Type 2 diabetes, Reuters said. The FDA requires companies making diabetes treatments to prove that their drugs do not increase the chance of heart attacks or other heart problems. Canagliflozin is part of a new class of diabetes medication, known as SGLT2 inhibitors. These drugs work by blocking reabsorption of glucose by the kidneys while increasing glucose excretion in urine to lower blood sugar, Reuters said.

FDA reviewers also believe the use of canagliflozin may be associated with adverse effects on the kidneys, as well as increased fungal growth in the perineum and bacterial growth in the urinary tract, Reuters said. FDA reviewers also carefully evaluated renal, adrenal, testicular, breast, and bladder cancers throughout the development of the treatment; available data did not point to an increased risk of malignancies related to the drug, Reuters said.

An independent panel of experts is scheduled to review and vote on the drug’s safety, efficacy, and approval on Thursday. Although the FDA does not have to follow the recommendation of the panel, it typically does. If approved, the drug will be sold as Invokana, Reuters said.

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