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Caution urged over use of fast-acting version of ketamine for depression

Caution urged over use of fast-acting version of ketamine for depression | Veterans Affairs and Veterans News from HadIt.com | Scoop.it

The FDA, under political pressure to rapidly greenlight drugs that treat life-threatening conditions, approved it anyway. And, though Spravato’s appearance on the market was greeted with public applause, some deep misgivings were expressed at its day-long review meeting and in the agency’s own briefing materials, according to public recordings, documents and interviews with participants, KHN found.

Theresa "Tbird" Aldrich's insight:

Ketamine and Veterans Affairs. Whats the rush to stock Spravato’s in VA's? Spravato’s approval got put on a fast track. From the article "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. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, raising red flags Janssen and the FDA dismissed."

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Veterans Affairs and Veterans News from HadIt.com

Curated by Theresa "Tbird" Aldrich