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FDA staff say J&J's new diabetes drug may pose heart risks

(Reuters) - A new kind of diabetes drug being developed by Johnson & Johnson raised the level of bad cholesterol in patients during clinical trials and may pose heart risks, U.S. drug reviewers said in documents published on Tuesday.

J&J is testing canagliflozin to treat Type 2 diabetes, which is often associated with obesity and a lack of exercise. Diabetes affects about 370 million people worldwide, and about 90 percent of those cases are Type 2 diabetes.

The FDA requires companies making treatments for the disorder to prove that their drugs do not increase the risk of heart attacks or other heart problems.

Reviewers with the U.S. Food and Drug Administration also said the use of the drug canagliflozin could be associated with potential adverse effects on the kidneys and increased fungal growth in the perineum and bacterial growth in the urinary tract.

An independent panel of experts will review and vote on the drug's safety, efficacy and approval on January 10. The FDA usually follows the panel's recommendations.

The drug will be sold as Invokana if approved.

Reviewers also said while renal, adrenal, testicular, breast and bladder cancers were carefully evaluated throughout the development of the treatment, available data did not suggest an increased risk of malignancies related to the drug.

Canagliflozin belongs to a new class of diabetes medication, known as SGLT2 inhibitors. These drugs work by blocking reabsorption of glucose by the kidneys and increases glucose excretion in urine to lower blood sugar.

AstraZeneca Plc and Bristol-Myers Squibb Co's dapagliflozin, which belongs to the same class, was rejected by the FDA last January over safety concerns, including liver problems.

Eli Lilly and Co and Boehringer Ingelheim's empagliflozin, which uses a similar mechanism, is currently in late-stage trials.

(Reporting by Esha Dey in Bangalore; Editing by Roshni Menon)

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