Since 1967, the Freedom of Information Act (FOIA) has provided the public the right to request access to records from any federal agency. It is often described as the law that keeps citizens in the know about their government. Federal agencies are required to disclose any information requested under the FOIA unless it falls under one of nine exemptions which protect interests such as personal privacy, national security, and law enforcement.
The use of the FDA’s Adverse Event Reporting System (FAERS) for broad post-approval drug safety studies has long been curtailed due to three assumed limitations of the dataset. AdverseEvents has systematically set out to debunk all three of these myths through the use of peer-reviewed studies in major academic journals. This blog article summarizes our findings and we invite you to review our complete journal articles for more details.
On June 3rd, the FDA launched OpenFDA, in an attempt to take large internal datasets and make them more accessible and usable by the developer and business community.
OpenFDA is delivered in a search-based API that should enable software developers to more easily build applications based on adverse event data from the FDA Adverse Event Reporting System (FAERS) dataset for the period 1/1/2004 to 6/30/3013. The FDA has announced plans to add device and food adverse events data to the framework, along with structured product labeling and recall data (update: drug and device recall data was added on July 16).
The launch was heralded with the sort of buzz and hoopla usually reserved for a major product launch from a Silicon Valley startup. I decided to hold off on any analysis and opinion until now to give our team the needed time to look through the system thoroughly.
The full study can be downloaded here.
Since AdverseEvents Explorer has been updated with 57,000 new unreleased FAERS reports generated from our Freedom of Information Act (FOIA) requests, AEI's sales team and account managers have been seeing a lot of client activity and questions around the new anticoagulant drugs. The general sentiment appears to be that given the similar efficacy profiles, payers and providers alike are taking a “wait-and-see” approach to determine how Eliquis’ (apixaban) post-approval safety profile stacks up to that of Xarelto’s (rivaroxaban) and Pradaxa’s (dabigaran).
To help AEI's clients make more informed decisions around these drugs (as well as the antiplatelet class), we used the AdverseEvents Explorer platform to analyze the FDA data (that only we had access to) in order to examine their comparative and relative safety.
Read the full report for the details, the top-line summary is that Eliquis has the best post-approval safety profile, beating out both Xarelto and Pradaxa.
As FiercePharma nicely put it, “AdverseEvents applies logic, math and software to the database [FAERS] in an attempt to sift out the important data.”
At AdverseEvents, we believe that monitoring and reviewing post-approval side effect data is vital to the analysis of a drug’s true safety profile. As we discuss in a recent White Paper entitled Post FDA-approval drug safety data: why they are vital and how they can be made accessible, actionable, and predictable, pre-approval clinical trials are, by necessity, conducted in relatively homogenous group. Trial subjects may react in similar ways to a test drug, and therefore, the clinical trail process does not uncover many of the side effects that occur once the drug is introduced to real-word, heterogeneous, patient populations. Therefore, a drug’s true side effect profile is almost never properly understood until many months to years after FDA approval.
A front-page article in yesterday’s Wall Street Journal brought this matter to the forefront once again with allegations of under-reporting of deaths and other serious outcomes and side effects during a major clinical trial of the anticoagulant drug Brilinta.
We have received an amazing response to our report -- Expediting Drug Safety Using FOIA: An Analysis of 57,000 New Unreleased FAERS Reports.
With the release of this previously unavailable data, pharmacy directors now have more information at their finger-tips to make better drug formulary decisions regarding newly approved drugs. Clinical pharmacists can now better pinpoint why their patients are experiencing certain ADEs. And drug safety industry followers can now utilize quality, standardized, and ACTIONABLE information that improves outcomes and lowers costs.
The December 9th issue of Vanity Fair includes a detailed expose on the contraception medication NuvaRing and its severe – sometimes deadly – side effects. Our analyst staff wrote an exceptional piece in our daily Drug Safety Monitor this morning that delved deeper into the issue by looking at conflicting clinical trial results and NuvaRing’s risk profile on a comparative and actionable basis.
I’m especially excited about our write-up on NuvaRing because it’s the first time we’ve included analysis from RxScore in the Drug Safety Monitor.
The centralized computerized information database for post-marketing drug safety surveillance is the FDA Adverse Event Reporting System (FAERS), which is currently growing by approximately 800,000 new cases per year. In 1993, FAERS (then referred to as AERS) launched with a simple, and worthy, goal: facilitate the reporting of post-approval ADEs. For healthcare professionals and consumers reporting is voluntary, but drug manufacturers must report all known ADEs to the FDA. In 2007, in order to enhance post-approval drug safety analysis even further, the FDA began to require drug companies to enact Risk Evaluation and Mitigation Strategies (REMS) to better manage, track, and report ADEs.
Its easy if you try.
If you are not familiar, FDA Safety Alerts are meant to update consumers and practitioners about new side effects that have emerged in post-marketed use and were previously not found, or disclosed, on the drug’s safety label. FDA Safety Alerts can take many forms. Most are warnings about a new side effect with appropriate label change, but more serious Alerts can lead to, and include Black Box warnings and product withdrawals and recalls.