Skip to Main Content

Drug makers must report side effects to regulators, but the amount of useful information can vary depending upon which regulator gets the data, according to a new analysis.

A team of researchers examined a dozen brand-name drugs used to treat depression and seizures and found that, on average, the manufacturers filed 77 more side effects reports with the US Food and Drug Administration than with the European Medicines Agency.


On average, 71 percent of the side-effect terms listed in the reports submitted to the FDA were not filed with the EMA, or vice versa. And in 86 percent of reports submitted to the FDA, there was more information on the source of the report — such as a spontaneous patient report during treatment or if it occurred during a trial — than what was provided to the EMA.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!