AdverseEvents Inc., a healthcare informatics company, released a special report titled “Expediting Drug Safety Using FOIA: An Analysis of 48,971 Unreleased FAERS Reports,” at TEDMED 2014 in San Francisco, California.
In response to the continued delayed release by the U.S. Food and Drug Administration (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.
The report in its entirety is available online.
Date: September 10, 2014
Source: AdverseEvents Inc.