FDA opioid approvals relied on short trials, patient exclusions, study contends

The research study likewise found that of the 21 products backed by a pivotal trial, 17 (81 percent) excluded participants who could not tolerate the drugs, and many trials stopped working to take a look at threats connected with drug, dependency and tolerance diversion. Its conclusion mentions that “systematic collation of particular important safety results was uncommon.”.

Katie Adams –
Tuesday, September 29th, 2020

None of the clinical trials for opioids the FDA approved to treat persistent discomfort from 1997 to 2018 lasted longer than 3 months, according to research study released Sept. 29 in Annals of Internal Medicine.

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Researchers found that just 21 of the 39 opioids approved by the FDA from 1997 to 2018 were supported by at least one essential trial. The median length of the trials carried out for opioids during this time was 84 days.