December 1, 2017

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

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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November 10, 2017

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

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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August 4, 2017

What happens when a Safety Signal contradicts Clinical Trial data?

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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March 24, 2017

Calculating the Reporting Rate of Adverse Events in FAERS – A New Methodology

It’s been an exciting week for drug safety with articles in both USA Today and FiercePharma examining the five-fold rise in reporting of serious adverse events into FDA’s Adverse Event Reporting System over the past twelve years.  We were thrilled to see Advera Health featured prominently in both of those articles.

Despite the significant reporting increase, limitations in the use of FAERS data for post-market surveillance remain.  One of the biggest limitations is that not all adverse events are reported.  As a spontaneous (i.e., voluntary) reporting system, it’s simply not possible for every adverse event to be recorded.  This is different from a controlled clinical trial where all adverse events and outcomes are recorded.

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