The December 9th issue of Vanity Fair includes a detailed expose on the contraception medication NuvaRing and its severe – sometimes deadly – side effects.  Our analyst staff wrote an exceptional piece in our daily Drug Safety Monitor this morning that delved deeper into the issue by looking at conflicting clinical trial results and NuvaRing’s risk profile on a comparative and actionable basis.

I’m especially excited about our write-up on NuvaRing because it’s the first time we’ve included analysis from RxScore in the Drug Safety Monitor. 

RxScore is our proprietary algorithmic scoring model that is based predominantly on post-marketed safety data from over five million FAERS reports. We present RxScore on a 100-point scale meant to reflect both the breadth and seriousness of side effect(s) by incorporating nine differentially weighted categories including FAERS fields such as “Outcome,” “Event Seriousness,” “Report Type,” and “Event Reporter,” a disproportionality measure, and existing FDA warnings and DEA risk classifications.  The score is also negatively adjusted by factoring in both “Condition Seriousness” and a patient’s existing comorbidities. A score of 100 indicates the highest potential adverse event risks.

In the case of NuvaRing, we note that, “ of the thirty drugs evaluated by AdverseEvents that are indicated for the prevention of pregnancy, NuvaRing has the fourth highest RxScore score.  This signifies an above average level of risk compared to those other drugs.”

That statement – “This signifies an above average level of risk compared to those other drugs” – seems innocuous, but it’s not. 

In fact, it’s quite revolutionary. 

Devising a system for comparable drug safety by class or indication is something we at AdverseEvents have spent almost three years working toward.  It enables the proactive improvement of patient outcomes and reduction of the overwhelming costs on the healthcare system caused by adverse drug events. 

Posted below is a screen shot of our RxScore comparison for drugs indicated for the prevention of pregnancy.  You can see all of the drugs that have a lower (safer) RxScore and the few that have a higher (riskier) score:

 

rxscore_nuvaring

 

You’ll be hearing a lot more about RxScore in the weeks and months ahead.  In the interim, we invite you to read our analysis piece on NuvaRing here or contact us here if you’d like more information about RxScore.



Brian Overstreet

Brian Overstreet

President

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Topics: FDA, FAERS, Drug / Indication Information, Drug Safety, Evidex

Brian Overstreet

Written by Brian Overstreet