Last week, pharmacovigilance news outlets announced the confirmation of one case of a serious adverse reaction from the multiple sclerosis (MS) drug Tecfidera. Reuters noted that this coincided with a 7 percent drop in Biogen Idec shares. The point of discussion here is a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML). This adverse reaction led to the market withdrawal of Tysabri in 2005, and has been associated with other MS drugs as well. Tysabri was returned to the market after increased safety measures were put in place, including a risk minimization program. In 2012, the FDA posted a Drug Safety Communication stating a Boxed Warning would be added to another MS drug, Adcetris, after just 3 cases of PML were reported in patients taking this drug.

Being that I work for a company that analyzes postmarketing drug safety data, I did some digging. Now, I did not track down that one case of PML related to Tecfidera because, as this singular case was very recently identified, it was not yet available in the most recent FAERS quarterly release. I could gripe about the lag-time between FAERS data releases, but I’ll save that for another time.

What I did find, however, both surprised and confused me, leading me to write this blog post. After looking through AdverseEvents Explorer, I collected data on 22 drugs that have 6 or more postmarketing reports of PML. What was even more interesting was that none of these drugs had this serious adverse reaction listed anywhere on their drug label. This is precisely the kind of situation where our offerings could and should be utilized to further investigate drug / adverse event pairs that pose a threat to patient safety.

Where else can you search a database of over 5 million case reports and quickly ascertain which drugs have elevated reporting rates for serious adverse reactions, whether those events are listed on the drug’s most recent label, how many case reports there are for those events, and get an idea of how many patients those reactions may actually affect?


Related Read: 3 Ways to Increase Adverse Event Reporting


Part of my job entails training our clients on all of the ways they can utilize the analytics and tools we offer on our platform, and I often get asked whether we work with the FDA on evaluating the safety of medications. I tell them that unfortunately, we don’t, but that I know the FDA could certainly benefit from utilizing the predictive algorithm we developed over the past couple of years to aid in their examination of postmarketing drug safety. We’ve laid the groundwork, and we are continually adding new features and improvements to our site. I don’t think anyone can deny the utility in being able to rapidly identify 22 drugs with multiple cases of PML.

Why is this important? Who is it useful for? I am the type of person that absolutely MUST be doing something impactful with my daily work, preferably with the end-goal of affecting the lives of individuals in a positive way. So for me, the main reason why AdverseEvents Explorer is an important tool is because Healthcare Decision Makers can use our RxSignal algorithm to identify “problem areas” for drugs, and use this information to incorporate safer drugs into their formularies, etc., thus effectively reducing the number of serious adverse events experienced by patients all over the nation. Additionally, this is useful for healthcare payers as they can prevent patient hospitalizations and injuries by covering safer drugs, leading to vast long-term monetary savings. Further, our platform can be utilized by liability insurers to assess the cost of claims & insurance for a particular company, by pharmaceutical companies to compare clinical trial data for their experimental medication to the postmarketing safety profile of competitors, by hedge fund analysts to help determine which drugs and/or pharma companies will be market movers, etc., etc.


Related Read: Pharma's Gonna Hate, and We Just Shake it Off


There are many ways that AdverseEvents Explorer can be applied, and we are learning more about our existing and potential client base every day.

This Company started because the founders realized the need for a platform that organized the FAERS dataset to make vital drug safety information actionable and accessible to everyone, with the hope that one day we’d be able to convey the importance and utility of these data to pharmacovigilance experts and healthcare decision makers. The information is here, and we’ve even cleaned it up to the point where you could honestly call it pretty. And we’re going to keep doing a stellar job until people in big pharma pay attention and take notes, and beyond.


Related Read: Monitoring the Safety of Biosimilars by Managed Care Organizations: A Practical Approach

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Andrea Demakas

Andrea Demakas

Product Specialist

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Topics: Drug Safety

Andrea Demakas

Written by Andrea Demakas