FDA Panel approves canagliflozin, new diabetes drug

Despite initial concerns that a new Johnson and Johnson diabetes drug poses health risks, a federal advisory panel approved the drug yesterday in a 10-5 vote.

Canagliflozin is part of a new class of drugs that help to lower blood sugar by encouraging the body to eliminate extra glucose through urine.

In clinical trials, patients taking canagliflozin showed improved blood sugar levels, weight loss and better blood pressure. But despite the FDA panel's approval, many people are still concerned about the safety of the drug.

Potential problems

Canagliflozin was shown to raise patients' levels of bad cholesterol, and it might also cause problems with bacterial growth in the urinary tract. In trials, the drug seemed to be less effective for people with poor kidney function, and it's currently not recommended for diabetics with kidney disease.

Panel experts were also concerned about the elevated risk for stroke and heart attack in patients taking canagliflozin.

“In the end, I found myself weighing a lot of ‘maybe’ benefits versus a lot of ‘maybe’ risks,” said panel member Edward W. Gregg of the Centers for Disease Control and Prevention. Gregg voted against the approval.

Working out the bugs

The panel hopes that the FDA can address the health concerns with Johnson and Johnson, perhaps requiring them to include warning labels. The FDA usually listens to panel decisions, though it is not required to comply.

Panel member Rebecca Killion voted in favor of the drug's approval, saying that it may be helpful for type 2 diabetics who are struggling with obesity.

“I think it particularly addresses concerns that patients have with respect to struggling with weight loss — which affects the progress of their disease — and the concern that all diabetic patients have about hypoglycemia,” Killon said.

Source: New York Times

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