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Items: 1 to 20 of 146

1.
2.
3.

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.

Brajovic S, Piazza-Hepp T, Swartz L, Dal Pan G.

Pharmacoepidemiol Drug Saf. 2012 Jun;21(6):565-70; discussion 571-2. doi: 10.1002/pds.3223. Epub 2012 Feb 22. Review.

PMID:
22359404
4.

Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001.

Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT.

MMWR Surveill Summ. 2003 Jan 24;52(1):1-24. Erratum in: MMWR Morb Mortal Wkly Rep. 2003 Feb 14;52(06):113.

5.

The role of databases in drug postmarketing surveillance.

Rodriguez EM, Staffa JA, Graham DJ.

Pharmacoepidemiol Drug Saf. 2001 Aug-Sep;10(5):407-10.

PMID:
11802586
6.

Topical bovine thrombin: a 21-year review of topical bovine thrombin spontaneous case safety reports submitted to FDA's Adverse Event Reporting System.

Clark JA, Humphries JE, Crean S, Reynolds MW.

Pharmacoepidemiol Drug Saf. 2010 Feb;19(2):107-14. doi: 10.1002/pds.1874. Review.

PMID:
20014051
8.

The FDA and drug safety: a proposal for sweeping changes.

Furberg CD, Levin AA, Gross PA, Shapiro RS, Strom BL.

Arch Intern Med. 2006 Oct 9;166(18):1938-42.

PMID:
17030825
10.

Likelihood ratio test-based method for signal detection in drug classes using FDA's AERS database.

Huang L, Zalkikar J, Tiwari RC.

J Biopharm Stat. 2013;23(1):178-200. doi: 10.1080/10543406.2013.736810.

PMID:
23331230
11.

Balancing drug risk and benefit: toward refining the process of FDA decisions affecting patient care.

Schiller LR, Johnson DA.

Am J Gastroenterol. 2008 Apr;103(4):815-9. doi: 10.1111/j.1572-0241.2008.01818.x.

PMID:
18397418
12.

Antipsychotics, glycemic disorders, and life-threatening diabetic events: a Bayesian data-mining analysis of the FDA adverse event reporting system (1968-2004).

DuMouchel W, Fram D, Yang X, Mahmoud RA, Grogg AL, Engelhart L, Ramaswamy K.

Ann Clin Psychiatry. 2008 Jan-Mar;20(1):21-31. doi: 10.1080/10401230701844612.

PMID:
18297583
13.

Torsades de pointes associated with fluoroquinolones.

Owens RC Jr, Ambrose PG.

Pharmacotherapy. 2002 May;22(5):663-8; discussion 668-72.

PMID:
12013370
14.

Pharmacovigilance in the 21st century: new systematic tools for an old problem.

Szarfman A, Tonning JM, Doraiswamy PM.

Pharmacotherapy. 2004 Sep;24(9):1099-104.

PMID:
15460169
16.

Reporting of adverse events to MedWatch.

Piazza-Hepp TD, Kennedy DL.

Am J Health Syst Pharm. 1995 Jul 1;52(13):1436-9.

PMID:
7671043
17.

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.

Hoffman KB, Dimbil M, Erdman CB, Tatonetti NP, Overstreet BM.

Drug Saf. 2014 Apr;37(4):283-94. doi: 10.1007/s40264-014-0150-2. Erratum in: Drug Saf. 2014 May;37(5):381.

18.

Recombinant human bone morphogenetic protein-2: adverse events reported to the Manufacturer and User Facility Device Experience database.

Woo EJ.

Spine J. 2012 Oct;12(10):894-9. doi: 10.1016/j.spinee.2012.09.052. Epub 2012 Oct 22.

PMID:
23098616
19.

An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in FDA's spontaneous adverse event reporting system.

Colman E, Szarfman A, Wyeth J, Mosholder A, Jillapalli D, Levine J, Avigan M.

Pharmacoepidemiol Drug Saf. 2008 Nov;17(11):1068-76. doi: 10.1002/pds.1643.

PMID:
18821724
20.

Monitoring adverse reactions to food additives in the U.S. Food and Drug Administration.

Tollefson L.

Regul Toxicol Pharmacol. 1988 Dec;8(4):438-46.

PMID:
3222485

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