The FDA publishes less than a third of research for drug safety updates, and Yale researchers said the "spontaneous reporting" highlights the need for greater transparency.
Six Yale students and professors evaluated drug safety signals — which are reports of potential adverse results from medications already on the market, according to the FDA — filed between 2008 and 2019.
The study, published Oct. 5 in BMJ, found that between 2014 and 2015, about 30 percent of resolved safety signals were published alongside at least one relevant study to corroborate the FDA's action.
"Greater transparency is needed around the evidence used to support regulatory actions to resolve safety signals, including what data were used when making the decision," the study's authors wrote in an opinion piece published in BMJ. "Such transparency is important as clinicians and patients may change prescribing or use patterns based on subsequent regulatory actions, and [they] would benefit from understanding the strength of the evidence behind these actions."