May 15, 2015 — The new type-2 diabetes drug Invokana has been linked to hundreds of serious adverse event reports in its first year on the market, according to a report by the Institute for Safety Medication Practices (ISMP).
The latest issue of the ISMP QuarterWatch (PDF) reported 457 adverse events involving Invokana, mostly falling 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)
The manufacturer of Invokana, Johnson & Johnson’s Janssen Pharmaceuticals unit, says all of these side effects are on the label except kidney stones.
Today, the FDA issued a Safety Communication to announce another potentially life-threatening side effect of Invokana known as diabetic ketoacidosis.
Invokana is the first FDA-approved drug in a new class of diabetes medications that work by helping the kidneys eliminate sugar through urine. Although clinical trials involved 10,000 patients, the ISMP cautioned that the studies were not sufficient to detmine whether Invokana had long-term benefits for people with type-2 diabetes.
The ISMP questioned whether uncertain benefits were worth the risk:
“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.”
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