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
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Published in |
Drug Safety, March 2014
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DOI | 10.1007/s40264-014-0150-2 |
Pubmed ID | |
Authors |
Keith B. Hoffman, Mo Dimbil, Colin B. Erdman, Nicholas P. Tatonetti, Brian M. Overstreet |
Abstract |
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 this effect in 1984 based upon a single class of medications prescribed in the United Kingdom. Since that time, the FDA has made a concerted effort to improve both reporting and the database itself. Both volume and quality of AE reporting has dramatically improved since Weber's report, with an estimated 800,000 yearly reports now being logged into FAERS. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Japan | 1 | 14% |
Unknown | 6 | 86% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 7 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Japan | 2 | 2% |
Ireland | 1 | <1% |
Finland | 1 | <1% |
Israel | 1 | <1% |
Denmark | 1 | <1% |
Egypt | 1 | <1% |
Unknown | 96 | 93% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Ph. D. Student | 22 | 21% |
Researcher | 15 | 15% |
Student > Master | 11 | 11% |
Student > Bachelor | 8 | 8% |
Student > Doctoral Student | 6 | 6% |
Other | 19 | 18% |
Unknown | 22 | 21% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 29 | 28% |
Pharmacology, Toxicology and Pharmaceutical Science | 17 | 17% |
Computer Science | 9 | 9% |
Agricultural and Biological Sciences | 5 | 5% |
Nursing and Health Professions | 3 | 3% |
Other | 11 | 11% |
Unknown | 29 | 28% |