The RxView Blog

Real world data, analytics, and insights for healthcare decision makers

Advera Health Analytics, Inc.

Post-Marketing Drug Safety and Pharmacovigilance Is Now More Important Than Ever

Posted by Jim Davis on May 12, 2017

If you read this blog, you probably follow the world of drug safety closely. So I’m sure you saw the JAMA article, and the resulting coverage by the main stream media, that was authored by Downing, et al., Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

If you haven’t had a chance to read the study yet, the results demonstrated that a third of every drug approved from 2001-2010 was subject to post-marketing action by FDA.  Even more alarming was the finding that drugs with accelerated approval by FDA during this period were twice as likely to be subject to label changes or warnings after approval. 

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Topics: Post Approval Data, Pharmacovigiance 2.0

Does Brilinta Really Have a Better Drug Safety Profile Than Plavix?

Posted by Jim Davis on February 4, 2014

At AdverseEvents, we believe that monitoring and reviewing post-approval side effect data is vital to the analysis of a drug’s true safety profile. As we discuss in a recent White Paper entitled Post FDA-approval drug safety data: why they are vital and how they can be made accessible, actionable, and predictable, pre-approval clinical trials are, by necessity, conducted in relatively homogenous group. Trial subjects may react in similar ways to a test drug, and therefore, the clinical trail process does not uncover many of the side effects that occur once the drug is introduced to real-word, heterogeneous, patient populations. Therefore, a drug’s true side effect profile is almost never properly understood until many months to years after FDA approval.

A front-page article in yesterday’s Wall Street Journal brought this matter to the forefront once again with allegations of under-reporting of deaths and other serious outcomes and side effects during a major clinical trial of the anticoagulant drug Brilinta.

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Topics: FAERS, Plavix, Bilinta, Post Approval Data

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