Monday, October 18, 2021

US opposition to ‘psychotropics’ opposed

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FDA

Controversial plans to expand American president Donald Trump’s use of the “psychotropics” have met stiff opposition.

On Wednesday, the Food and Drug Administration’s Advisory Committee voted 14-4 against government-mandated research into the effects of the “benzodiazepines” – commonly referred to as the “cough syrup pill”. The plan would have put a day one “new drug application” on the horizon.

The FDA currently considers the medications to be safe and effective drugs for adults with an anxiety disorder. In 2012, the federal agency ended an eight-year study into the medications when a higher than average number of deaths were reported. The recommendation to expand use of the medication to all adults was in-part because of findings suggesting the medications aren’t effective in treating obsessive-compulsive disorder (OCD) in a small number of patients, with some studies suggesting they could decrease a patient’s tolerance to medications.

The advisory committee held the first part of a two-day meeting on Wednesday and Thursday. The event began on Wednesday morning with deliberations on the merits of adding the benzos to the existing registry, and ended with a joint statement from the groups opposed to the advisory committee’s decision and those in favor of expanding their use.

The FDA declined to comment on the consultation process. It will make a final decision later this year.

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