Neither FDA Nor EMA Provide Adequate Information About Drug Side Effects, Says Study | Pharma Industry Regulation |

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.

Most drug makers report incomplete side effects to the FDA
The upshot: On average, only 29 percent of the side effects were reported to both agencies. Moreover, most of the reports lacked information on duration and seriousness of the side effects, as well as the extent to which the reactions were reversible.

“This study shows that the reporting of drug adverse effects on product information is fragmentary and inconsistent,” said study author Moore. “In this sample, neither the FDA nor the EMA versions provided much information about the onset, duration, and severity of drug side effects. Instead they provided just lists that were not necessarily in agreement.”