Earlier this month FDA quietly published a quarterly update to their publicly available “watch list” of ongoing drug safety concerns. The updates are based on Q1 2017 FDA Adverse Event Reporting System (FAERS) data. You can download a copy of our recent Evidex Alert, covering the new additions, clarifications, and “all clears” so I won’t get into the details in this post. However, it is worth noting that there were fourteen unique drugs, or in some cases entire classes of drugs, that were included in the update. Many of the drugs have been on market for quite a long time and otherwise would be considered to have a well established safety profile. For 8 of the 11 alerts that could be signaled for (3 of the alerts were AEs that were already labeled for), Advera Health’s RxSignal early warning system did its job and picked up on the signal. The remaining alerts either weren't on a RxSignal eligible adverse event, meaning it wasn't a serious event that the FDA typical takes action on, but there was noticable elevated reporting as defined by reporting odds ratios (ROR).
This post isn’t one of our classic pat-ourselves-on-the-back brags, a critique on the agency, or a dig at the manufacturers. The fact is, there isn’t much to comment on that is obvious; Our RxSignal analytic did its job and our Evidex clients already knew about these signals. FDA did theirs by further analyzing the potential risks and communicating their findings in a timely manner. And manufacturers did their job by efficiently collecting and submitting the reports to the agency. All-in-all this update is fairly “boring” as far as drug safety stories go.
With that said, I see three major talking points from this update. Not on the drugs or the risks themselves, but general pharmacovigilance themes.
First, the update makes clear that FAERS data and other spontaneous reporting databases remain the cornerstone of signal detection. As we discussed in our recent post, Failure to Warn, FDA has recently come out and openly backed the use of FAERS for detecting signals and how the dataset complements the power of Sentinel for evaluating signals. In order to properly refine and evaluate safety issues, you need a place to start. FAERS will remain that place for the foreseeable future.
Second, as noted in the opening paragraph several of the drugs in the update have been on the market for quite some time and are considered “established”. This highlights that even older drugs should still be questioned and surveilled closely. We’ve debunked the reporting myth called the Weber Effect that states ALL new drugs see spikes in reporting within the first two years on market, followed by a plateau and drop off. While not an “effect” that can apply to all drugs, the phenomenon can be seen with some. Perhaps if more healthcare professionals understood that safety risks will continuously emerge, reporting on all drugs would be higher. Or as Brian pointed out in his recent post on Canada’s path to requiring reporting, perhaps mandatory reporting requirements could help ensure as much data as possible are being collected.
Third, with drug safety science, and the platforms that support it, advancing in leaps and bounds the ability to refine and evaluate a safety signal doesn’t need to rest solely with FDA. The quarterly watch list that FDA releases remains relevant, however with platforms available that can combine disparate datasets for analysis, evaluation is not something that should be solely be the responsibility of FDA. Now that we are collectively pulling our heads out of the sand, we can as an industry, come to scientific conclusions more efficiently and effectively.
The fact that the most recent FDA watch list update can be considered “boring” is a very good thing. It signals that the basic, fundamental job of pharmacovigilance is being met and the focus can turn to continuing to advance drug safety as a science.
For an in-depth analysis of the signals mentioned in the update, download the Evidex Alert, Analysis of Q1 2017 FDA Safety Signals.
For more info on the FDA Adverse Event Reporting System, see our comprehensive guide to FAERS.