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canakinumab (ILARIS)

Additional Information from Public Citizen

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    Follow-up letter to the Office for Human Research Protections regarding a clinical study testing the drug canakinumab in children with type I diabetes failed to satisfy the requirements of HHS regulations regarding informed consent for research.
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    We oppose the Food and Drug Administration’s (FDA) approval of canakinumab, a potent immunosuppressant agent, for the treatment of patients with gouty arthritis attacks because the drug has serious, life-threatening risks that far outweigh the drug’s clinical benefits, which are limited primarily to relief of pain from acute gout flares in this patient population.

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