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FDA Approves J&J Diabetes Drug Invokana Despite Risks

susan_harr3 years ago

Johnson & Johnson’s Janssen Pharmaceuticals Unit has received FDA approval for its new diabetes drug, Invokana (canagliflozin). The drug is the first in a new class of Type 2 Diabetes meds dubbed SGLT2 inhibitors; drugs in this class work by reducing the amount of sugar absorbed in the body and flushing any excess out through the urine.

Invokana has the potential to offer an innovative means to battle the disease (which affects approx. 26 million Americans) but also showed serious risks, including heart attack and stroke, in clinical trial patients.

Risks Linked to J&J’s New Diabetes Drug- Invokana

According to several published reports, Invokana reportedly caused a variety of side effects in clinical trial patients, including:

  • Elevated stroke risk (within the first 30 days)
  • Increase in heart attack risk (within the first 30 days)
  • Drops in blood pressure
  • Rise in LDL cholesterol levels
  • Urinary tract infections (UTIs) and yeast infections

FDA Orders Additional Studies on Invokana

According to the FDA, Janssen is required to complete 5 post marketing studies on Invokana, including:

  • A cardiovascular outcomes trial;
  • A bone safety study;
  • Two pediatric safety studies;
  • And an enhanced pharmacovigilance program to monitor for:

    • malignancies
    • serious cases of pancreatitis
    • severe hypersensitivity reactions
    • photosensitivity reactions
    • liver abnormalities
    • adverse pregnancy outcomes
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