Bob Kyle

Bob Kyle

Recent Posts

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?

Read More
September 4, 2015

RxSignal 3.0 - Predicting FDA Label Changes


We are proud to announce after months of hard work and dedication from everyone on the Advera Health development team that we have launched the newest version of RxSignal. RxSignal is our proprietary tool which identifies serious adverse events which are most likely to be added to a drug’s label in the future. This latest version produces more accurate signals that lead to label changes involving more important medical events while producing a lower number of signals that do not lead to label changes or actions by the FDA.  

Read More