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FDA identifies stumbling blocks for new diabetes drug

Jan 9, 2013

The Food and Drug Administration issued a statement this week indicating that a clinical trial of a new type 2 diabetes drug has suffered some setbacks as there have been a rash of dangerous side effects reported among its participants.

According to a Reuters report, the FDA published a report this week on the developments of a clinical trial on the prospective Johnson & Johnson drug canagliflozin, a proposed new prescription drug treatment in the fight against type 2 diabetes. The agency said early results of a clinical trial of the drug show that increases a person's levels of bad cholesterol to the point where the drug poses heart risks to a patient taking it.

This side effect is bad news for diabetics, who are more often than not overweight or obese and face the greatest risk of diabetes-related death from heart disease. The FDA requires any new type 2 diabetes drug that gets its approval to be free of the risk of causing heart-related complications. This development obviously impedes this drug's progress past the agency and to prescribing physicians.

The agency also noted in its study that patients in the trial had also shown to have suffered adverse effects on their kidneys and increased fungal growth in the perineum and bacterial growth in the urinary tract, according to the report. A final review of the drug is expected on June 10 when FDA officials will vote on the drug's overall safety and whether or not to recommend it for approval.

The indications are that this panel may choose to send the drug back for more development, especially to work on lowering the risk of heart-related side effects or to at least identify certain patients who may be more at risk of suffering heart-related problems while taking canagliflozin. Testing during the trial to find out if taking the drug increased the risk of cancer of the kidneys, adrenal glands, testes, breasts, and bladder were negative.

If Johnson & Johnson is successful in getting canagliflozin approved for use, the company plans to market it as Invokana. 

If it is approved, it will join other drugs in a class known as SGLT2 inhibitors, a newer treatment of type 2 diabetes, a disease that is growing at a rate to be considered a public health epidemic. Millions of Americans have been diagnosed with type 2 diabetes and the disease figures to affect more Americans in the future as lifestyles become more sedentary and diets become more unhealthy.

Current and previous drug treatments for type 2 diabetes have only enjoyed moderate levels of success but many people taking them have suffered serious and sometimes fatal side effects of the drug.

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