Adverse event reports rise rapidly even as Trump promises faster drug approvals

Fierce Pharma ------- Even as the new administration is promising to sweep away some FDA practices to speed drugs to market, a new study has found that there has been a dramatic rise in the number of drug side effects reported in recent years. According to the analysis by the Milwaukee Journal and MedPage Today, there were 1.2 million reports filed with the FDA’s adverse events reporting system in 2015, up from 206,000 in 2004, a five-fold increase. From the beginning there have been criticisms of the limits of the info entered into the FDA Adverse Event Reporting System (FAERS), and even the FDA says because of those, it should not be used for research. The agency points out that a report of an adverse event while taking a drug doesn’t mean it was actually caused by the drug and that the data should not be used to estimate risk. To get more in depth information click on the picture below to read the article.