Invokana (canaglifozin) has been approved by the US Food and
Drug Administration to treat type 2 diabetes, which affects about 24 million
The drug is among a new class of medications called
sodium-glucose co-transporter 2 inhibitors. It works to block re-absorption 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
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