The RxView Blog

Real world data, analytics, and insights for healthcare decision makers

Advera Health Analytics, Inc.

Analysis of a FDA Safety Signal: DPP-4's and Rhabdomyolysis

By Jim Davis on December 1, 2017

Recently the FDA published the Q2 2017 version of Potential Signals of Serious Risks / New Safety Information as identified by the FDA Adverse Event Reporting System (FAERS).

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Topics: FAERS, Clinical Evidence, Evidex, Drug / Indication Information

Evidex Goes Global - VigiBase Drug Safety Data Access

By Brian Overstreet on November 22, 2017

Last week we announced the addition of VigiBase global safety data to the Evidex platform. VigiBase is the unique global database of individual safety reports collected from over 110 countries by the World Health Organization. It totals over 15 million adverse event reports since 1968 and is administered by the Uppsala Monitoring Centre in Sweden.

This is an exciting development for our company, for our clients, and for the drug safety community at large.

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Topics: FAERS, Evidex, Pharmacovigiance 2.0, VigiBase

An Analysis of Adverse Events Associated with Endothelin Receptor Antagonists (ERAs) using FAERS

By Jim Davis on November 10, 2017

Advera Health released a new functionality framework in Evidex this week called Custom Analytics. The goal of Custom Analytics is to provide Evidex users an easy way to perform complex queries across all of the clinical, spontaneous and other real-world data included in the Evidex platform and to return a filtered set of specific information. 

We have launched Custom Analytics with a Custom Drug-Adverse Event Analysis search function. With the Custom Drug-Adverse Event Analysis, users can easily filter case reports by specific drug combinations, demographic, and descriptive information, create customized MedDRA queries with multiple preferred terms, and calculate Reporting Odds Ratios (RORs).

The best part? It's simple to use.

Let's demonstrate the power of Custom Analytics through a case study, analyzing adverse events associated with endothelin receptor antagonists (ERAs) using the FDA Adverse Event Reporting System (FAERS) data. 

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Topics: FAERS, Clinical Evidence, Pharmacovigiance 2.0, Company News

Santa Rosa Wildfires - A Very Tough Week at Advera Health

By Brian Overstreet on October 20, 2017

Santa Rosa, California in Sonoma County is where we live and work.  It's probably best known for its world class wines, restaurants, and hotels.

Last week, we made global news for a much different reason.

Starting early in the morning on Monday Oct 9, a series of wildfires tore through the city of Santa Rosa and the surrounding areas. By the end of the week, thousands of homes and commercial buildings had burned, more than 40 people had died, and another 50+ remained missing. For a county with a total population less than 500,000 and fewer than 200,000 housing units, the effect on our home town has been devastating.

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Topics: Company News

FAERS Thee Well - Drug Safety Excitement with FDA Dashboard

By Brian Overstreet on October 6, 2017

It’s been an exciting week in the normally staid world of drug safety.  

Last Thursday, FDA launched a public dashboard for FAERS (the FDA Adverse Event Reporting System).  We’ve been calling on FDA to do this for years, so we were quite excited to read the news and take the new dashboard out for a spin.

Apparently, a lot of others were just as excited.  The site almost immediately stopped working and stayed that way for most of Friday. 

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Topics: FDA, FAERS

Dear FDA, There is No Single Truth Standard

By Jim Davis on September 29, 2017
FDA needs to think of itself as an information curator, rather than an arbiter of information, FDA Commissioner Scott Gottlieb told attendees of the National Academy of Sciences’ workshop on the impact of real-world evidence ( RWE) on Tuesday, September 19th. Further stating, where a single truth standard is secured to a fixed orthodoxy”. 
 
If only it were that easy. 
 
A single truth standard sounds great in a world where patients are homogeneous, human biology is fully understood, and motivated trial sponsors don’t design studies to hit specific goals. 
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Topics: FDA, Real World Evidence

How Pharmacovigilance Departments Can Work Smarter, Act Bigger

By Jim Davis on September 15, 2017

Most pharmacovigilance departments are resource constrained. Whether its human capital, budget, or both, the drug safety specialists within pharmaceutical companies are being asked to do a whole lot with very little.

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Topics: Pharmacovigiance 2.0

Case Studies: Signal Detection Utilizing FDA Adverse Event Reporting System (FAERS) Data

By Jim Davis on August 25, 2017

One of the key benefits of a drug safety evidence aggregation platform is the data source flexibility it provides. Historically, smaller organizations have put off automating aggregate signal detection on FDA Adverse Event Reporting System (FAERS) data to avoid the cost and time commitment needed to implement traditional signal detection software. And those organizations that do have traditional software installed, have typically limited use to specific functional areas within drug safety and “expert” users, making FAERS data and analytics hard to access. An evidence aggregation platform makes these data and the related analytics easy and provides for a robust source of insight.

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Topics: Pharmacovigiance 2.0

What happens when a Safety Signal contradicts Clinical Trial data?

By Bob Kyle on August 4, 2017

Last month, FDA released their quarterly watch list of ongoing drug safety concerns. My colleague Jim wrote a blog post on some of the major talking points around the update, not on the drugs or the risks themselves, but general pharmacovigilance themes. Our post this week focuses on one of the risks that was specifically discussed by FDA on the SGLT-2 class of diabetes drugs. The SGLT-2's had triggered a safety signal for nephrolithiasis (aka kidney stones). Evidex RxSignal analysis had also predicted this safety signal for most of these SGLT-2 drugs, with many of the signals being triggered more than a year prior to this alert.

However, unlike the 12 other safety issues in this same alert, the FDA quickly determined that despite the safety signal shown in the postmarketing data, “no action is necessary at this time, based on available information”. In other words, the FDA does not believe that kidney stones should be disclosed as a risk to the labels of these medications.

Why did the FDA make this determination so quickly? What information did the FDA use?

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Topics: FDA, Clinical Evidence, Evidex

FDA Releases Q1 2017 Drug Safety Watch List: It’s Boring and That’s Good

By Jim Davis on July 21, 2017

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). 

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Topics: FDA, Evidex, Pharmacovigiance 2.0

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