SANTA ROSA, Calif., September 10, 2014 – AdverseEvents Inc., a healthcare informatics company, released today at TEDMED 2014 in San Francisco, CA a Special Report: Expediting Drug Safety Using FOIA: An Analysis of 48,971 Unreleased FAERS Reports.

In response to the continued delayed release by the FDA of drug safety data from the FDA Adverse Event Reporting System, AdverseEvents has been filing Freedom of Information Act (FOIA) requests for high profile individual drugs that are of the most concern to healthcare decision makers.

In response to the FOIA requests on 152 drugs through June 2014, the FDA provided 88,922 pages of unstandardized data, in PDF format.  Incorporating this data into the AdverseEvents Explorer platform resulted in the extraction of 48,971 new primary suspect cases yet to be seen outside of FDA and drug manufactures.

AdverseEvents released the report to coincide with its' participation in TEDMED 2014, a conference dedicated to the idea that technology will radically alter the healthcare landscape. The release highlights the power of AdverseEvents proprietary data mining capabilities and more importantly the analytics and insight that enables healthcare decision makers to drive safer prescribing behavior that improves patient outcomes and reduces the estimated $27 billion burden that avoidable side effects have on the healthcare system.

AEI's FOIA request and processing methods revealed significant safety concerns that have yet to be communicated by FDA or drug manufacturers. The drug safety information revealed in this report provides not only the data, but AdverseEvents' analytics and accompanying insight that cannot be found from any other source.

AdverseEvents' FOIA Report contains the following:
• Drugs that have experienced significant increased serious side effects that are not currently being communicated to healthcare providers and the general public
• 12 drugs with an Active RxSignal1 that have shown an increased likelihood that the FDA will take future regulatory action
• 20 drugs with large increases in RxScore2, indicating a dramatic negative shift in the post market safety profile
In addition, the report also provides insight on the marketplace battle between the obesity drugs Qsymia and Belvig, with new side effect data that potentially will play a role in determining a marketshare winner. Also featured, are new alternatives to statins and a review of the sudden spike in deaths associated with Zemplar, a now generic drug whose safety profile went from average to risky during this period.
• To view the report in its entirety please click here.

1 RxScore® is the first drug safety scoring system that compiles available drug information and quickly summarizes comprehensive post-approval drug safety issues.
2 RxSignal® is a predictive algorithm that alerts users to emerging and/or previously unidentified side effect threats that may prompt a future FDA regulatory action (warnings, Black Box designations, product withdrawal or recalls, etc).
About Adverse Events, Inc.
AdverseEvents, Inc. (AEI) is a California-based healthcare informatics company that improves patient safety and reduces systemic healthcare costs through the comprehensive analysis of post-marketing drug side effect data. Utilizing data-mining and analysis technology, through its proprietary RxSuite™ of analytics, AEI makes post-marketing drug safety data accessible, actionable, and predictable.

In addition to managed care organizations, AEI also provides services to enterprise markets including the pharmaceutical industry and financial institutions.

• Please note - This report MAY NOT BE REPRODUCED, DISPLAYED, MODIFIED, DISTRIBUTED or LINKED TO without the express prior written permission of the copyright holder. AdverseEvents Inc's research may be cited but not excerpted in its entirety. For permission, contact [email protected]
• Disclaimer: AdverseEvents, nor its officers or employees, has been directly compensated by any party for the preparation of this report. The inclusion of a particular company, drug, class or indication in this report is determined wholly by our quantitative signaling and scoring systems along with our qualitative analysis work. The inclusion or exclusion of any drug, company, or indication has not, and will not, be influenced by any third party, including any clients of AdverseEvents.

Suggested Articles

Already developing coronavirus treatments, Takeda struck a licensing deal to manufacture and market Novavax's vaccine candidate in Japan

Pfizer struck a deal to produce Gilead Sciences' remdesivir, which has been running short at some hard-hit U.S. hospitals.

AZ licenses COVID-19 vaccine to BioKangtai in China. Pfizer and BioNTech will supply 120 million doses of their shot to Japan. Legend CEO resigned.