A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports-Reference-Cited by-同舟云学术

A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports

Published:2016-03-05 Issue:6 Volume:39 Page:561-575
ISSN:0114-5916
Container-title:Drug Safety
language:en
Short-container-title:Drug Saf

Author:

Hoffman Keith B.,Dimbil Mo,Tatonetti Nicholas P.,Kyle Robert F.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Link

http://link.springer.com/content/pdf/10.1007/s40264-016-0409-x.pdf

Reference40 articles.

1. Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration. J Gen Int Med. 2003;18(1):57–60.

2. FDA. Follow-up to the November 2009 early communication about an ongoing safety review of sibutramine, marketed as Meridia. 2010 [online]. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm198206.htm . Accessed 3 Feb 2016.

3. FDA. Safety Information: Vioxx (rofecoxib). 2002 [online]. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm154520.htm . Accessed 3 Feb 2016.

4. Charatan F. Bayer decides to withdraw cholesterol lowering drug. BMJ. 2001;323(7309):359.

5. Tang E, Ravaud P, Riveros C, Perrodeau E, Dechartres A. Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles. BMC Med. 2015;13:189.

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