MONDAY, April 1 (HealthDay News) -- Invokana (canaglifozin) has been approved by the U.S. Food and Drug Administration to treat type 2 diabetes, which affects about 24 million Americans.
The drug is among a new class of medications called sodium-glucose co-transporter 2 inhibitors. It works to block reabsoprtion of glucose by the kidneys, leading to more glucose being excreted by the body, the agency said in a news release.
The drug's safety and effectiveness were evaluated in nine clinical trials involving more than 10,200 people. The trials showed improvement in blood glucose levels and glucose control, the FDA said.
Invokana, which users should combine with proper diet and exercise, shouldn't be taken by people with type 1 diabetes, by those who have elevated ketones of the blood or urine, or by people with kidney impairment or end stage renal disease, the FDA said.
The most common side effects noted during clinical testing included vaginal yeast infection and urinary tract infection. The FDA said it's ordering five post-marketing studies to evaluate the drug's effects on children, the cardiovascular system, and the potential for increased risk of cancer, pancreatitis, severe hypersentivity reactions, adverse pregnancy outcomes, bone safety, and liver abnormalities.
The drug may lead to a sudden drop in blood pressure when a user stands up, the agency said.
Invokana is produced for Janssen Pharmaceuticals of Titusville, N.J.
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-- Scott Roberts
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