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FDA overlooked red flags in drugmaker's testing of new depression medicine
APhA: FDA in March approved a ketamine cousin called esketamine (Spravato—Janssen), taken as a nasal spray, for patients with intractable depression. Critics claim Janssen provided the agency at best modest evidence it worked and then only in limited trials. It presented no information about the safety of esketamine for long-term use beyond 60 weeks. Three patients who received the drug died by suicide during clinical trials, compared with none in the control group, raising concerns Janssen and FDA dismissed.
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