Document Detail


Identifying patterns of adverse event reporting for four members of the angiotensin II receptor blockers class of drugs: revisiting the Weber effect.
MedLine Citation:
PMID:  18636418     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: To evaluate the evidence for temporal reporting patterns, such as the Weber effect, in spontaneous post-marketing adverse event (AE) reports submitted to the Food and Drug Administration (FDA), for four members of the angiotensin II receptor blockers drug class (ARBs).
METHODS: For losartan, valsartan, irbesartan, and candesartan, we evaluated temporal trends in reporting for the total number of AE reports, serious AE reports, and direct reports from consumers or health care providers (direct reports) to FDA. Reporting patterns were considered consistent with the Weber effect when the peak occurred 2 years after US marketing and the number of reports declined thereafter. We tabulated the number of reports by year since the first report. We adjusted the total number of reports, number of serious AE reports, and number of direct reports by the number of US dispensed prescriptions.
RESULTS: There were no clear temporal reporting patterns for the total number of reports, direct reports, or serious AE reports. We observed a consistent trend for the adjusted number of direct and serious AE reports. The adjusted number was highest in the first year and continually decreased over time for all four ARBs. For the adjusted total number of reports, the decline was not constant over time.
CONCLUSION: A characteristic temporal pattern in the adjusted number of reports, in which the adjusted number was highest in the first year and declined thereafter, was identified. However, we did not observe a pattern consistent with the Weber effect for these four ARBs.
Authors:
Mara A McAdams; Laura A Governale; Lynette Swartz; Tarek A Hammad; Gerald J Dal Pan
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Pharmacoepidemiology and drug safety     Volume:  17     ISSN:  1099-1557     ISO Abbreviation:  Pharmacoepidemiol Drug Saf     Publication Date:  2008 Sep 
Date Detail:
Created Date:  2008-08-26     Completed Date:  2009-01-27     Revised Date:  2013-05-28    
Medline Journal Info:
Nlm Unique ID:  9208369     Medline TA:  Pharmacoepidemiol Drug Saf     Country:  England    
Other Details:
Languages:  eng     Pagination:  882-9     Citation Subset:  IM    
Affiliation:
Office of Surveillance and Epidemiology, Food & Drug Administration, Silver Spring, MD 20993-0002, USA. mara.mcadams@fda.hhs.gov
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MeSH Terms
Descriptor/Qualifier:
Adverse Drug Reaction Reporting Systems / trends*
Angiotensin II Type 1 Receptor Blockers / adverse effects*
Antihypertensive Agents / adverse effects
Benzimidazoles / adverse effects*
Biphenyl Compounds / adverse effects*
Drug Approval / methods
Humans
Losartan / adverse effects*
Tetrazoles / adverse effects*
Time Factors
United States
Valine / adverse effects,  analogs & derivatives*
Chemical
Reg. No./Substance:
0/Angiotensin II Type 1 Receptor Blockers; 0/Antihypertensive Agents; 0/Benzimidazoles; 0/Biphenyl Compounds; 0/Tetrazoles; 114798-26-4/Losartan; 137862-53-4/valsartan; 138402-11-6/irbesartan; 7004-03-7/Valine; S8Q36MD2XX/candesartan

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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