Hammad TA, Pinheiro SP, Neyarapally GA. Secondary use of randomized controlled trials to evaluate drug safety: a review of methodological considerations. Clin Trials 2011; 8(5): 559-70.
Alves C, Macedo AF, Marques FB. Sources of information used by regulatory agencies on the generation of drug safety alerts. Eur J Clin Pharmacol 2013; 69(12): 2083-94.
Hauben M, Aronson JK. Defining “signal”and its subtypes in pharmacovigilance based on a systematic review of previous definitions. Drug Saf 2009; 32(2): 99-110.
Bate A, Evans SJW. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf 2009; 18(6): 427-36.
Madigan D, Ryan P, Simpson S, Zorych I. Bayesian Methods in Pharmacovigilance. In: Bernardo JM, Bayarri M, Berger J, Dawid A, D.H. Smith, Eds. Bayesian Statistics 9. Oxford: Oxford University Press 2010.
Hauben M, Reich L. Communication of findings in pharmacovigilance: use of the term “signal” and the need for precision in its use. Eur J Clin Pharmacol 2005; 61(5-6): 479-80.
Moher D, Liberati A, Tetzlaff J, Altman DG. for the PRISMA Group. Preferred reporting items for systematic reviews and metaanalyses: The PRISMA statement. PLoS Med 2009; 151(4): 264-9. W64
Khadem TM, Manen RPvan, Brown J. How safe are recently FDA-approved antimicrobials? A review of the FDA Adverse Event Reporting System Database. Pharmacotherapy 2014; 34(12): 1324-9.
Gahr M, Zeiss R, Lang D, et al. Risk of bleeding related to selective and non-selective serotonergic antidepressants : a case / non-case approach using data from two pharmacovigilance databases. Pharmacopsychiatry 2015; 48: 19-24.
Mcdonald CJ, Kalisch LM, Barratt JD, Caughey GE. A cross-country comparison of rivaroxaban spontaneous adverse event reports and concomitant medicine use with the potential to increase the risk of harm. Drug Saf 2014; 37: 1029-35.
Haber P, Moro PL, Mcneil MM, et al. Post-licensure surveillance of trivalent live attenuated influenza vaccine in adults, United States, vaccine adverse event reporting system (VAERS), July 2005 – June 2013. Vaccine 2014; 32(48): 6499-504.
Biagi C, Conti V, Montanaro N, Melis M, Buccellato E. Comparative safety profiles of intravitreal bevacizumab, ranibizumab and pegaptanib : the analysis of the WHO database of adverse drug reactions. Eur J Clin Pharmacol 2014; 70: 1505-12.
Raschi E, Poluzzi E, Koci A, Caraceni P, Ponti FD. Assessing liver injury associated with antimycotics : Concise literature review and clues from data mining of the FAERS database. World J Hepatol 2014; 6(8): 601-12.
Napoli AA, Wood JJ, Coumbis JJ, Soitkar AM, Seekins DW, Tilson HH. No evident association between efavirenz use and suicidality was identified from a disproportionality analysis using the FAERS database. J Int AIDS Soc 2014; 17: 1-4.
Moulis G, Sommet A, Lapeyre-Mestre M, Montastruc J-L. for the Association Française des Centres Régionaux de PharmacoVigilance. Is the risk of tumour necrosis factor inhibitor-induced lupus or lupus-like syndrome the same with monoclonal antibodies and soluble receptor? A case/non-case study in a nationwide pharmacovigilance database. Rheumatology (Oxford) 2014; 53(10): 1864-71.
Viola E, Opri S, Moretti U, et al. α 1 -Adrenergic receptor antagonists and gynecomastia. A case series from the Italian spontaneous reporting system and VigiBaseTM. Eur J Clin Pharmacol 2014; 70: 1003-9.
Takada M, Fujimoto M, Yamazaki K, Takamoto M, Hosomi K. Association of statin use with sleep disturbances: Data mining of a spontaneous reporting database and a prescription database. Drug Saf 2014; 37: 421-31.
Béné J, Moulis G, Auffret M, et al. Alopecia induced by tumour necrosis factor-alpha antagonists: Description of 52 cases and disproportionality analysis in a nationwide pharmacovigilance database. Rheumatol (United Kingdom) 2014; 53(8): 1465-9.
Mendes D, Alves C, Batel-Marques F. Safety profiles of adalimumab, etanercept and infliximab: A pharmacovigilance study using a measure of disproportionality in a database of spontaneously reported adverse events. J Clin Pharm Ther 2014; 39(3): 307-13.
Fujimoto M, Hosomi K, Takada M. Statin-associated lower urinary tract symptoms: data mining of the public version of the FDA adverse event reporting system, FAERS. Int J Clin Pharmacol Ther 2014; 52(4): 259-66.
Ali AK. Peripheral neuropathy and Guillain-Barré syndrome risks associated with exposure to systemic fluoroquinolones: A pharmacovigilance analysis. Ann Epidemiol 2014; 24(4): 279-85.
Ali AK. Pharmacovigilance analysis of serious averse events reported for biologic response modifiers used as prophylaxis against transplant rejection: a real-world postmarketing experience from the US FDA adverse event reporting system (FAERS). Int J Organ Transplant Med 2013; 4(2): 62-71.
Brinker AD, Lyndly J, Tonning J, Moeny D, Levine JG, Avigan MI. Profiling cumulative proportional reporting ratios of drug-induced liver injury in the FDA Adverse Event Reporting System (FAERS) database. Drug Saf 2013; 36(12): 1169-78.
Raisch D, Garg V, Arabyat R. Anaphylaxis associated with gadolinium-based contrast agents: data from the Food and Drug Administration’s adverse event reporting system and review of case. Exp Opin Drug Saf 2014; 13(1): 15-23.
Moro PL, Harrington T, Shimabukuro T, et al. Adverse events after Fluzone ® Intradermal vaccine reported to the Vaccine Adverse Event Reporting System (VAERS), 2011-2013. Vaccine 2013; 31(43): 4984-7.
Roberto G, Piccinni C, D’Alessandro R, Poluzzi E. Triptans and serious adverse vascular events: data mining of the FDA Adverse Event Reporting System database. Cephalalgia 2014; 34(1): 5-13.
Hauben M, Hung EY. Pneumothorax as an adverse drug event: an exploratory aggregate analysis of the US FDA AERS database including a confounding by indication analysis inspired by Cornfield’s condition. Int J Med Sci 2013; 10(8): 965-73.
Yoshimura K, Kadoyama K, Sakaeda T, Sugino Y, Ogawa O, Okuno Y. A survey of the FAERS database concerning the adverse event profiles of α1-adrenoreceptor blockers for lower urinary tract symptoms. Int J Med Sci 2013; 10(7): 864-9.
Pugi A, Bonaiuti R, Maggini V, et al. Safety profile of antiviral medications: a pharmacovigilance study using the Italian spontaneous-reporting database. Am J Health Syst Pharm 2013; 70(12): 1039-46.
Buccellato E, Biagi C, Vaccheri A, Melis M, Montanaro N, Motola D. Possible occurrence of paraesthesia in patients taking norethisterone: an analysis on the WHO Global Individual Case Reports database (VigiBase). Expert Opin Drug Saf 2013; 12(5): 615-9.
Hauben M, Hung EY. A quantitative analysis of the spontaneous reporting of congestive heart failure-related adverse events with systemic anti-fungal drugs. J Clin Pharmacol 2013; 53(7): 762-72.
Martin D, Menschik D, Bryant-Genevier M, Ball R. Data mining for prospective early detection of safety signals in the Vaccine Adverse Event Reporting System (VAERS): a case study of febrile seizures after a 2010-2011 seasonal influenza virus vaccine. Drug Saf 2013; 36(7): 547-56.
Hoog SL, Cheng Y, Elpers J, Dowsett SA. Duloxetine and pregnancy outcomes: safety surveillance findings. Int J Med Sci 2013; 10(4): 413-9.
Okon E, Engell C, van Manen R, Brown J. Tigecycline-related pancreatitis: a review of spontaneous adverse event reports. Pharmacotherapy 2013; 33(1): 63-8.
Ali A and , Hartzema AG. Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting. J Asthma Allergy 2012; 5: 1-9.
Motola D, Biagi C, Leone R, et al. Ticlopidine safety profile: a case/non-case study on the basis of the spontaneous ADRs reporting in Italy. Curr Drug Saf 2012; 7(2): 99-105.
Schmedt N, Andersohn F, Garbe E. Signals of progressive multifocal leukoencephalopathy for immunosuppressants: a disproportionality analysis of spontaneous reports within the US Adverse Event Reporting System (AERS). Pharmacoepidemiol Drug Saf 2012; 21(11): 1216-20.
Tamura T, Sakaeda T, Kadoyama K, Okuno Y. Omeprazole- and esomeprazole-associated hypomagnesaemia: data mining of the public version of the FDA Adverse Event Reporting System. Int J Med Sci 2012; 9(5): 322-6.
Kadoyama K, Sakaeda T, Tamon A, Okuno Y. Adverse event profile of tigecycline: data mining of the public version of the U.S. Food and Drug Administration adverse event reporting system. Biol Pharm Bull 2012; 35(6): 967-70.
Shamloo BK, Chhabra P, Freedman AN, Potosky A, Malin J, Weiss Smith S. Novel adverse events of bevacizumab in the US FDA adverse event reporting system database: a disproportionality analysis. Drug Saf 2012; 35(6): 507-18.
Moro PL, Arana J, Cano M, et al. Postlicensure safety surveillance for high-dose trivalent inactivated influenza vaccine in the Vaccine Adverse Event Reporting System, 1 July 2010-31 December 2010. Clin Infect Dis 2012; 54(11): 1608-14.
Caillet C, Chauvelot-Moachon L, Montastruc J-L, Bagheri H. Safety profile of enantiomers vs racemic mixtures: it’s the same? Br J Clin Pharmacol 2012; 74(5): 886-9.
Motóla D, Piccinni C, Biagi C, et al. Cardiovascular, Ocular and Bone Adverse Reactions Associated with Thiazolidinediones. A disproportionality Analysis of the US FDA Adverse Event Reporting System Database. Drug Saf 2012; 35(4): 315-23.
Leroy Z, Broder K, Menschik D, Shimabukuro T, Martin D. Febrile seizures after 2010-2011 influenza vaccine in young children, United States: a vaccine safety signal from the vaccine adverse event reporting system. Vaccine 2012; 30(11): 2020-3.
Kadoyama K, Miki I, Tamura T, Brown JB, Sakaeda T, Okuno Y. Adverse event profiles of 5-fluorouracil and capecitabine: data mining of the public version of the FDA Adverse Event Reporting System, AERS, and reproducibility of clinical observations. Int J Med Sci 2012; 9(1): 33-9.
Sakaeda T, Kadoyama K, Okuno Y. Statin-associated muscular and renal adverse events: data mining of the public version of the FDA adverse event reporting system. PLoS One 2011; 6(12)e28124
Kadoyama K, Kuwahara A, Yamamori M, Brown JB, Sakaeda T, Okuno Y. Hypersensitivity reactions to anticancer agents: data mining of the public version of the FDA adverse event reporting system, AERS. J Exp Clin Cancer Res 2011; 30(1): 93.
Brown J, Aitken SL, van Manen RP. Potential for linezolid-related blindness: a review of spontaneous adverse event reports. Pharmacotherapy 2011; 31(6): 585-90.
Tuccori M, Lapi F, Testi A, Ruggiero E. Drug-Induced Taste and Smell Alterations. Drug Saf 2011; 34(10): 849-59.
Sakaeda T, Kadoyama K, Yabuuchi H, et al. Platinum agent-induced hypersensitivity reactions: data mining of the public version of the FDA adverse event reporting system, AERS. Int J Med Sci 2011; 8(4): 332-8.
Ben-Hamou M, Marshall NS, Grunstein RR, Saini B, Fois RA. Spontaneous adverse event reports associated with zolpidem in Australia 2001-2008. J Sleep Res 2011; 20(4): 559-68.
Willemen MJ, Mantel-Teeuwisse AK, Straus SM, Meyboom RH, Egberts TC, Leufkens HG. Use of dipeptidyl peptidase-4 inhibitors and the reporting of infections: a disproportionality analysis in the World Health Organization VigiBase. Diabetes Care 2011; 34(2): 369-74.
Muhammad RD, Haber P, Broder KR, et al. Adverse Events Following Trivalent Inactivated Influenza Vaccination in Children: Analysis of the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J 2010; 30(1): 1-8.
Ferrajolo C, Capuano A, Verhamme KMC, et al. Drug-induced hepatic injury in children: a case/non-case study of suspected adverse drug reactions in VigiBase. Br J Clin Pharmacol 2010; 70(5): 721-8.
Giezen T, Mantel-Teeuwisse A. Mapping the Safety Profile of Biologicals. Drug Saf 2010; 33(10): 865-78.
Schwan S, Sundström A, Stjernberg E, Hallberg E, Hallberg P. A signal for an abuse liability for pregabalin--results from the Swedish spontaneous adverse drug reaction reporting system. Eur J Clin Pharmacol 2010; 66(9): 947-53.
Mannesse C, van Pijenbroek E, Jansen P, van Marum R, Souverein P, Egberts T. Hyponatraemia as an Adverse Drug Reaction of Antipsychotic Drugs. A Case-Control Study in VigiBase. Drug Saf 2010; 33(7): 569-78.
Rivkees SA, Szarfman A. Dissimilar hepatotoxicity profiles of propylthiouracil and methimazole in children. J Clin Endocrinol Metab 2010; 95(7): 3260-7.
Poluzzi E, Raschi E, Motola D, Moretti U, De Ponti F. Antimicrobials and the risk of torsades de pointes: the contribution from data mining of the US FDA Adverse Event Reporting System. Drug Saf 2010; 33(4): 303-14.
Strandell J, Bate A, Hägg S, Edwards IR. Rhabdomyolysis a result of azithromycin and statins: an unrecognized interaction. Br J Clin Pharmacol 2009; 68(3): 427-34.
Slade BA, Leidel L, Vellozzi C, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009; 302(7): 750-7.
Do C, Huyghe E, Lapeyre-Mestre M, Montastruc J-L, Bagheri H. Statins and Erectile Dysfunction: Results of a Case/Non-Case Study Using the French Pharmacovigilance System Database. Drug Saf 2009; 32(7): 591-7.
Poluzzi E, Raschi E, Biolsc UM, Ponti F De. Drug‐induced torsades de pointes: data mining of the public version of the FDA Adverse Event Reporting System (AERS). Pharmacoepidemiol Drug Saf 2009; 18(l): 512-8.
Yang X, Brandenburg N. Venous Thromboembolism in Myelodysplastic Syndrome Patients Receiving Lenalidomide. Clin Drug Investig 2009; 29(3): 161-71.
Baker RA, Pikalov A, Tran Q-V, Kremenets T, Arani RB, Doraiswamy PM. Atypical antipsychotic drugs and diabetes mellitus in the US Food and Drug Administration Adverse Event database: a systematic Bayesian signal detection analysis. Psychopharmacol Bull 2008; 42(1): 11-31.
Andersohn F, Garbe E. Cardiac and noncardiac fibrotic reactions caused by ergot-and nonergot-derived dopamine agonists. Mov Disord 2009; 24(1): 129-33.
Chen Y, Guo JJ, Healy DP, Lin X, Patel NC. Risk of hepatotoxicity associated with the use of telithromycin: a signal detection using data mining algorithms. Ann Pharmacother 2008; 42(12): 1791-6.
Tuccori M, Moretti U, Lapi F. Statin-associated psychiatric adverse events: A case/non case evaluation of an Italian database of spontaneous reporting of adverse drug reactions. Drug Saf 2007; 31(12): 1115-24.
Knudsen JF, Sokol GH, Flowers CM. Adjunctive topiramate enhances the risk of hypothermia associated with valproic acid therapy. J Clin Pharm Ther 2008; 33(5): 513-9.
Salvo F, Polimeni G, Cutroneo PM, et al. Allergic reactions to oral drugs: A case/non-case study from an Italian spontaneous reporting database (GIF). Pharmacol Res 2008; 58(3-4): 202-7.
Hagg S, Bate A, Stahl M, Spigset O. Associations Between Venous Thromboembolism and Antipsychotics. A Study of the WHO Database of Adverse Drug Reactions. Drug Saf 2008; 31(8): 685-94.
Hauben M, Vegni F, Reich L, Younus M. Postmarketing hepatic adverse event experience with PEGylated/non-PEGylated drugs: a disproportionality analysis. Eur J Gastroenterol Hepatol 2007; 19(11): 934-41.
Carvajal A, Macias D, Gutiérrez A, et al. Gynaecomastia associated with proton pump inhibitors: a case series from the Spanish Pharmacovigilance System. Drug Saf 2007; 30(6): 527-31.
Salvo F, Polimeni G, Moretti U, et al. Adverse drug reactions related to amoxicillin alone and in association with clavulanic acid: data from spontaneous reporting in Italy. J Antimicrob Chemother 2007; 60(1): 121-6.
Hauben M, Horn S, Reich L, Younus M. Association between gastric acid suppressants and Clostridium difficile colitis and community-acquired pneumonia: analysis using pharmacovigilance tools. Int J Infect Dis 2007; 11(5): 417-22.
Motola D, Vargiu A, Leone R, et al. Hepatic adverse drug reactions: a case/non-case study in Italy. Eur J Clin Pharmacol 2007; 63(1): 73-9.
Szarfman A, Tonning JM, Levine JG, Doraiswamy PM. Atypical antipsychotics and pituitary tumors: a pharmacovigilance study. Pharmacotherapy 2006; 26(6): 748-58.
Polimeni G, Salvo F, Cutroneo P, Morreale I, Caputi A. Adverse reactions induced by NSAIDs and antibacterials. Drug Saf 2006; 29(5): 449-59.
Hauben M, Reich L, Gerrits C. Reports of hyperkalemia after publication of RALES—a pharmacovigilance study. Pharmacoepidemiol Drug Saf 2006; 15(11): 775-83.
Leone R, Conforti A, Venegoni M, et al. Drug-Induced Anaphylaxis Case / Non-Case Study Based on an Italian. Drug Saf 2005; 28(6): 547-56.
Montrastruc JL, Sommet A, Bagheri H, Lapeyre-Mestre M. Benefits and strengths of the disproportionality analysis for the identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol 2011; 72(6): 905-8.