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

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.  

Not surprisingly, 7 of the 10 drugs accounting for the most reports have FDA black box warnings for side effects. Among the drugs with the most reports were AbbVie’s rheumatoid arthritis drug Humira and Celgene’s cancer drug Revlimid.   

A Celgene spokesperson pointed out that with a drug like Revlimid, the FDA’s system will have difficulty separating the worsening effects of cancer, or another medical condition, from side effects. A spokesperson for AbbVie pointed out to the publications that Humira “has a well-established safety profile and is a trusted treatment.” She said the company does rigorous safety analyses of its products and provides detailed safety reviews to the FDA and other regulators around the world.

One of the criticisms of the system has been that because it is only drug companies that are required to report, not doctors or patients, it is probably only picking up a small percent of the total number of side effects, although some people think that the public and doctors are becoming more aware of the system and so contributing more reports.

Brian Overstreet of Advera Health Analytics, which analyzes FAERS for pharmaceutical companies, health insurers, and hospital systems, says the industry figures the database has historically captured about 10% of adverse events. But he said the “sheer increase in volume and some other factors mean that this percentage is starting to increase.”

Advera next week will present findings from its own study about why that might be, and what it might mean for the industry. “In short what we found is that reporting rates vary widely by indication, with some reporting as many as 50% of all serious AEs and some much less than the 10% estimate,” Overstreet said today in an email.

All of these findings come as President Trump has promised the industry that he will streamline the FDA to speed drugs to the market faster and just picked former agency insider Scott Gottlieb to do just that.

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As that comes to pass, Overstreet says the FAERS system, regardless of its limitations, will become more important. Given that drugs tested in limited clinical trials may have much different effects in the real world, he thinks it is essential to the industry that the database be maintained and analyzed.

“As new drugs are brought to market faster, maintaining vigilance around post-market surveillance via FAERS is going to be increasingly critical,” Overstreet said. “And frankly it’s the only mechanism we currently have to track that safety evolution.”