Invokana Linked to Hundreds of Adverse Events

Invokana Linked to Hundreds of Adverse EventsMay 15, 2015 — During the first year Invokana was on the market, it was associated with over 450 adverse events — many involving kidney failure, kidney impairment, or problems with kidney stones, urinary tract infections, and more.

According to the latest QuarterWatch report (PDF), issued by the Institute for Safe Medication Practices (ISMP), the FDA received 457 adverse event reports for Invokana in the first 12 months it was on the market.

Side effect reports mostly fell into six categories:

  • Renal failure or impairment (54 reports)
  • Kidney stones (11 reports)
  • Fluid/electrolyte issues (54 reports)
  • Urinary tract infections (50 reports)
  • Weight-loss (52 reports)
  • Hypersensitivity (50 reports)

These side effects are all included in the Prescribing Information, with the exception of kidney stones.

The ISMP warned that although Invokana was tested in more than 10,000 patients, the studies were not long enough to establish whether it had a measurable clinical benefit on the long-term complications of type-2 diabetes.

The organization concluded:

“The central unanswered question about [Invokana] —which extends in a different form to other diabetes medications—is whether the drug does more good than harm in long-term treatment. … We observe clear evidence of harm to some patients in terms of hypersensitivity reactions and an array of renal adverse effects.”

Today the FDA issued a Safety Communication to warn about the risk of diabetic ketoacidosis, a potentially life-threatening side effect from Invokana and other drugs in the SGLT2 class.

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