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?

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April 7, 2017

Evidex Alerts After 3 Months: What We’ve Learned

It has now been one full quarter since we launched Evidex Alerts, the service which keeps our clients on top of the latest Drug Label Changes, Regulatory Alerts and Clinical Safety Data in real-time.   Evidex Alerts have been a smashing success and our clients have openly thanked us making this information easier to follow.  One client in particular was amazed at how well we untangle the mess that is a drug label and pull out the important pieces of information that they need to know, when they need to know it.

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January 20, 2017

Real-Time Drug Safety Analysis with Evidex Alerts

This week we launched Evidex Alerts, a new feature that provides our clients with real-time updates on the latest impactful drug safety news. This is a project that our development and analyst teams have worked on diligently for the last three months, and I am excited to announce that it became a reality this week. 

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November 3, 2016

A Drug Safety Data Point That No One Knows About

In the Q3 2014 FDA Adverse Event Reporting System (FAERS) data file, FDA quietly added a new field that links a patient and case report to a literature reference. Or in other words, there is additional information on the adverse event (AE) report that previously was not available. These literature references can provide beneficial context to the patient case report, validate or refute a causal relationship to an adverse event, and often times bring to the surface data that is otherwise undiscoverable.

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December 4, 2015

JMCP Validates the Ability to Quantify the Safety Risk of Drugs

JMCP_Cover.pngFor the last few years, we have been working continuously to turn post-market patient data from the FDA’s Adverse Reporting system (FAERS) into insight that can be used by healthcare providers to quantify the costs and risks associated with the drugs that their patients are prescribed.  Along the way, we have had a number of “naysayers” tell us it cannot be done. 

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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.  

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May 22, 2015

Predicting the Future? Yes, we can.


A few weeks ago, I was on a call with one of our Business Development Managers, explaining the details of our proprietary analytics to a Pharmacy Director at a health plan that we were trying to turn into a client. We were walking through our RxSignal technology for a particular drug and the executive said to us, “This looks great but you can’t possibly predict what the FDA is going to do in the future”.

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February 20, 2015

RxOutcome – A New Paradigm in Drug Safety


I’m pleased to share the news that this week we launched RxOutcome.

RxOutcome is a powerful new dashboard on the AdverseEvents Explorer platform that allows our clients to compare drugs across an indication, class, or mechanism of action.

With RxOutcome, subscribers can now compare actual incidence rates and patient outcome rates of a group of medications to see which drug is the safest option or which drug causes particular safety issues versus others in its peer group.

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October 15, 2014

Chantix: Why the Black Box Warning Should Remain

Tomorrow, there will be an FDA panel meeting where a committee of drug safety and pharmacology experts will decide whether Chantix’s black box warning for neuropsychiatric events should be removed from its label. This warning has been on the label since 2008, when the FDA found in its Adverse Event Reporting System (FAERS) a number of suicide-related, mood-related and aggression related events that were large enough in scope to cause the FDA to require this change. In my opinion, this black box warning should not be removed at this time.

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August 8, 2014

August: Now The Scariest Month of the Year for Pharma Companies

It’s that time of year again. It’s August, the summer is winding down and people are taking their last vacations before the kids go back to school. Football players are in training camp and baseball pennant races are coming down to the wire. And most importantly to all of us at AdverseEvents, Prescription Benefit Managers (PBMs) are telling the world which drugs they are excluding from their preferred drug formulary coverage in 2015.

Last week, we found out that Express Scripts and CVS Caremark will be excluding two drugs from their respective formularies, Vimovo (naproxen/esomeprazole) and Duexis (ibuprofen/famotidine). The news was not so good for the maker of those drugs, Horizon Pharma, whose stock is down more than 30% since the announcement was made. Horizon stated in their 8-K that these formulary deletions could cost them 30% of their revenue and the market reacted accordingly. These drugs both combine an anti-inflammatory agent with an anti-ulcer agent, seemingly a very logical and safer combination since heavy anti-inflammatory use can sometimes cause ulcers. However, each individual component of these drugs is available much cheaper if they were prescribed separately. Based on this, Express Scripts and CVS decided the combination drug was a waste of money (namely theirs) and they weren’t going to tolerate it anymore. Now, everybody is speculating whether other combination drugs that combine cheap generic individual components are next on the PBMs’ chopping block.

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