The Weber Effect and the United States Food and Drug Administration’s Adverse Event Reporting System (FAERS): Analysis of Sixty-Two Drugs Approved from 2006 to 2010

@inproceedings{Hoffman2014TheWE,
  title={The Weber Effect and the United States Food and Drug Administration’s Adverse Event Reporting System (FAERS): Analysis of Sixty-Two Drugs Approved from 2006 to 2010},
  author={Keith B. Hoffman and Mo Dimbil and Colin B. Erdman and Nicholas P. Tatonetti and Brian Overstreet},
  booktitle={Drug safety},
  year={2014}
}
BACKGROUND The United States Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) consists of adverse event (AE) reports linked to approved drugs. The database is widely used to support post-marketing safety surveillance programs. Sometimes cited as a limitation to the usefulness of FAERS, however, is the 'Weber effect,' which is often summarized by stating that AE reporting peaks at the end of the second year after a regulatory authority approves a drug. Weber described… CONTINUE READING
Related Discussions
This paper has been referenced on Twitter 8 times. VIEW TWEETS

From This Paper

Figures, tables, and topics from this paper.

Citations

Publications citing this paper.
Showing 1-10 of 11 extracted citations

References

Publications referenced by this paper.
Showing 1-10 of 49 references

Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs

J. Weber
Adv Inflamm Res • 1984
View 4 Excerpts
Highly Influenced

Evaluation and Mitigation Strategies (REMS)

FDA. Approved Ris
2007. http://www.fda.gov/drugs/drugsafety/postmarket drugsafetyinformationforpatientsandproviders/ucm111350.htm. Accessed Feb • 2014
View 7 Excerpts
Highly Influenced

National Drug File Reference Terminology

FDA. Pharmacological Class
2013. http://www.fda.gov/ForIndustry/DataStandards/ StructuredProductLabeling/ucm162549.htm. Accessed Feb • 2014
View 3 Excerpts
Highly Influenced

in Food and Drug Law History

FDA. Milestone
2005. http:// www.fda.gov/aboutfda/whatwedo/history/milestones/ucm081229. htm. Accessed Feb • 2014
View 7 Excerpts
Highly Influenced

Reporting System (FAERS) (formerly AERS)

FDA U. FDA Adverse Even
2012. http://www.fda.gov/drugs/guidance complianceregulatoryinformation/surveillance/adversedrugeffects/ default.htm. Accessed Feb • 2014
View 1 Excerpt

Scheme—new medicines and vaccines subject to EU-wide additional monitoring

MHRA. Black Triangl
United Kingdom. 2014. http://www.mhra.gov.uk/Safetyinformation/Howwemonitorthe safetyofproducts/Medicines/BlackTriangleproducts/index.htm. Accessed Feb • 2014
View 1 Excerpt

Vioxx (rofecoxib)

FDA. Safety Information
2002. http://www. fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsfor HumanMedicalProducts/ucm154520.htm. Accessed Feb • 2014

and Reports Entered into AERS by Year

FDA U. Reports Receive
2013. http://www.fda.gov/Drugs/GuidanceCompliance RegulatoryInformation/Surveillance/AdverseDrugEffects/ucm07 0434.htm. Accessed Feb • 2014
View 1 Excerpt

to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia

FDA. Follow-U
2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafety InformationforPatientsandProviders/DrugSafetyInformationfor HeathcareProfessionals/ucm198206.htm. Accessed Feb • 2014

A Drug Safety ePlatform for Physicians , Pharmacists and Consumers based on PostMarketing Adverse Events

KB Hoffman, BM Overstreet, PM. Doraiswamy
Drugs and Therapy Studies • 2013

Similar Papers

Loading similar papers…