Recently, Advera Health released a comparative safety report of the HER2+ Antagonists. In this drug review, we analyzed FDA Adverse Event Reporting System (FAERS) and clinical trial data to better understand how the drugs in this class stacked up.
Seventy two hours after 2016 Q2 FDA Adverse Event Reporting System (FAERS) data were publicly released by FDA, our RxFilter® process had it standardized and loaded into the Evidex platform. Based on the volume of data in Q2, it looks like we’re well on the way to yet another record year of adverse events reported into FAERS.
Here is a chart of new case reports (including our estimate for full year 2016). Note that these numbers are based on a clean dataset; de-duplicated, primary suspect cases only).
I’m writing this in the lobby of a car dealership, waiting for my vehicle to get serviced. I brought a couple of sales books with me so I could utilize the 2 hour wait. I recently took on the added role of part-time sales rep within Advera Health as I have experienced successful case studies first-hand through being our client-facing Product Specialist over the past two years: I’ve built relationships with our existing clients, received their feedback on our data tools & analytics to see how they’ve implemented the information, and witnessed how our Evidex platform has become an integral part of their workflow.
We are pleased to report that our latest major publication, “A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports” was released this week in the esteemed journal “Drug Safety.” It was published as an online-first feature and will also appear in the April copy of the print version of Drug Safety.
One year after its birth, the ultimate data parasite has come of age by latching on to a $3 billion host. It is big, blue, pretty good at Jeopardy, and if you were to believe the data detractors, utterly useless.
On Wednesday, Jan. 6, Forbes ran an article detailing a 7% drop in the price of Regeneron’s (REGN) stock price. The company attributed that decline to investors obtaining data from the FDA Adverse Events Reporting System (FAERS) showing eight suicide cases from patient’s taking Regeneron’s new PCSK9 inhibitor Praluent (alirocumab).
The issue, of course, was that the people who obtained those data knew nothing about FAERS or its myriad problems with case duplications, incomplete records, or how to value reports submitted with multiple drugs and/or from dubious sources.
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.