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Code Red: FDA Approves Another Dangerous Gout Drug

The FDA just approved IV drug Krystexxa for gout treatment, but according to Health Science Institute, they couldn’t possibly have looked at the trial results. Fewer than half the people in the trial actually ended up with a positive result, the Institute said. On top of that:

On top of that, Krystexxa produced some pretty nasty adverse reactions, such as:

  • 41 percent of the patients suffered severe infusion reactions, despite taking antihistamines and steroids before their Krystexxa treatment
  • 77 percent suffered from gout flare-ups, compared to 51 percent taking placebo – and that’s despite being pretreated for at least a week with NSAIDs, colchicine, or both

Not to mention an unusually large percentage of anaphylactic reactions (again, despite premedicating with antihistamines and steroids!), and other very unpleasant side effects like chest pain, nausea, vomiting, and bruises.

Other adverse reactions listed on the manufacturer’s package insert included an increase in gout flare-ups.