-- Scott Roberts
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
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
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,
Visit Medline Plus to learn more about
type 2 diabetes.
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