FDA Overlooked Red Flags In Drugmaker’s Testing of New Depression Medicine
By Editor - Tue Jun 11, 3:26 am
Ketamine is a darling of combat medics and clubgoers, an anesthetic that can quiet your pain without suppressing breathing and a hallucinogenic that can get you high with little risk of a fatal overdose. For some patients, it also has dwelled in the shadows of conventional medicine as a depression treatment — prescribed by their doctors, but not approved for that purpose by the federal agency responsible for determining which treatments are “safe and effective.” That effectively changed in March, when the Food and Drug Administration approved a ketamine cousin called esketamine, taken as a nasal spray, for patients with intractable depression. With that, the esketamine nasal spray, under the brand name Spravato, was introduced as a miracle drug — announced in press releases, celebrated on the evening news and embraced by major health care providers like the Department of Veterans Affairs . The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks.
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