Integrating evidence from multiple sources to evaluate post-approval safety: an example of sildenafil citrate and cardiovascular events

References

• Russell S. FDA posts web site on Viagra deaths – up to 16, but cause unclear. San Francisco Chronicle 1998 Wednesday. June 10;Sect. A-7
   Google Scholar
• Braun M, Klotz T, Mathers M, . ‘Viagra effect’ – influence of mass media on patient behavior. Urol Int 2001; 66:145–8
   PubMed Web of Science ®Google Scholar
• Rosen RC. Sildenafil: medical advance or media event? Lancet 1998; 351:1599
   PubMed Web of Science ®Google Scholar
• Mitka M. Some men who take Viagra die – why? JAMA 2000; 283:590–1
   PubMed Web of Science ®Google Scholar
• Schwartz J. Viagra's hidden risks. Washington Post 1998 Tuesday, June 9;Sect. Z12
   Google Scholar
• Schwartz J. Deaths of 6 Viagra users studied. Washington Post 1998 Saturday, May 23;Sect. A02
   Google Scholar
• US Food and Drug Administration. Pfizer updates Viagra labeling. November 24, 1998. Available at: http://www.fda.gov/bbs/topics/ANSWERS/ANS00926.html [Last accessed 18 March 2008]
   Google Scholar
• Ahmad SR, Goetsch R, Marks N. Spontaneous reporting in the United States. Pharmacoepidemiology, 4th ednStrom BL. Chichester, UK: John Wiley & Sons, 2005
   Google Scholar
• Edwards I, Olsson S, Lindquist M, Hugman B. Global Drug Surveillance. The WHO Programme for International Drug Monitoring. Pharmacoepidemiology, 4th ednStrom BL. Chichester, UK: John Wiley & Sons, 2005
   Google Scholar
• US Food and Drug Administration. Guidance For Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, 2005. Available at: http://www.fda.gov/cber/gdlns/pharmacovig.htm [Last accessed 2 July 2007]
   Google Scholar
• European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on risk management systems for medicinal products for human use 2005. Available at: http://www.emea.europa.eu/pdfs/human/euleg/9626805en.pdf [Last accessed 2 July 2007]
   Google Scholar
• Weber JCP. Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs. Advances in Inflammation ResearchRainsford KD, Velo GP. New York, NY: Raven Press, 1984;1–7
   Google Scholar
• Hartnell NR, Wilson JP. Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration. Pharmacotherapy 2004; 24:743–9
   PubMed Web of Science ®Google Scholar
• Hartnell NR, Wilson JP, Patel NC, . Adverse event reporting with selective serotonin-reuptake inhibitors. Ann Pharmacother 2003; 37:1387–91
   PubMed Web of Science ®Google Scholar
• Wallenstein EJ, Fife D. Temporal patterns of NSAID spontaneous adverse event reports: the Weber effect revisited. Drug Saf 2001; 24:233–7
   PubMed Web of Science ®Google Scholar
• Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther 1998; 20 (Suppl C) 40–4
   PubMed Web of Science ®Google Scholar
• Kirby M, Jackson G, Betteridge J, Friedli K. Is erectile dysfunction a marker for cardiovascular disease? Int J Clin Pract 2001; 55:614–18
   PubMed Web of Science ®Google Scholar
• Selvin E, Burnett AL, Platz EA. Prevalence and risk factors for erectile dysfunction in the US. Am J Med 2007; 120:151–7
   PubMed Web of Science ®Google Scholar
• Bacon CG, Mittleman MA, Kawachi I, . A prospective study of risk factors for erectile dysfunction. J Urol 2006; 176:217–21
   PubMed Web of Science ®Google Scholar
• Thompson IM, Tangen CM, Goodman PJ, . Erectile dysfunction and subsequent cardiovascular disease. JAMA 2005; 294:2996–3002
   PubMed Web of Science ®Google Scholar
• Mittleman MA, Maclure M, Lewis MA, . Cardiovascular outcomes among sildenafil users: results of the International Men's Health study. Int J Clin Pract 2008; 62:367–73
   PubMed Web of Science ®Google Scholar
• Dow Jones & Company. Factiva Database 2008. Available at: http://www.factiva.com/[Last accessed 13 March 2008]
   Google Scholar
• Padma-Nathan H, Eardley I, Kloner RA, . A 4-year update on the safety of sildenafil citrate (Viagra®). Urology 2002; 60 (Suppl 2B) 67–90
   PubMed Web of Science ®Google Scholar
• Data on file. Pfizer IncNew York, NY. 2003. File PSUR-03–2003
   Google Scholar
• Jackson G, Gillies H, Osterloh I. Past, present, and future: a 7-year update of Viagra® (sildenafil citrate). Int J Clin Pract 2005; 59:680–91
   PubMed Web of Science ®Google Scholar
• Data on file. Pfizer IncNew York, NY. 2007. File SCS-1.4.1–2007
   Google Scholar
• International Conference on Harmonisation. MedDRA Coding Dictionary. Available at: http://www.meddramsso.com/MSSOWeb/index.htm [Last accessed 10 March 2008]
   Google Scholar
• Meinzinger MM, Barry WS. Prospective study of the influence of the media on reporting medical events. Drug Inf J 1990; 24:575–7
   Google Scholar
• American Heart Association. Men and cardiovascular diseases: 2007 update. Available at: http://www.americanheart.org/presenter.jhtml?identifier=3000935 [Last accessed 2 July 2007]
   Google Scholar
• Tunstall-Pedoe H, Kuulasmaa K, Mahonen M, . Contribution of trends in survival and coronary-event rates to changes in coronary heart disease mortality: 10-year results from 37 WHO MONICA project populations. Monitoring trends and determinants in cardiovascular disease. Lancet 1999; 353:1547–57
   PubMed Web of Science ®Google Scholar
• Williams D, Feely J. Initial uptake in use of sildenafil in general practice. Eur J Clin Pharmacol 2001; 56:911–14
   PubMed Web of Science ®Google Scholar
• Shakir SAW, Wilton LV, Boshier A, . Cardiovascular events in users of sildenafil: results from first phase of prescription event monitoring in England. BMJ 2001; 322:651–2
   PubMed Web of Science ®Google Scholar
• Boshier A, Wilton LV, Shakir SA. Evaluation of the safety of sildenafil for male erectile dysfunction: experience gained in general practice use in England in 1999. BJU Int 2004; 93:796–801
   PubMed Web of Science ®Google Scholar
• Marchione M. Diabetes Drug Side Effect Reports Triple. US News and World Report 2007. Available at: http://hosted.ap.org/dynamic/stories/D/DIABETES_DRUG_RISKS?SITE=DCUSN&SECTION=HOME&TEMPLATE=DEFAULT [Last accessed 17 July 2007]
   Google Scholar
• Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; 356:2457–71
   PubMed Web of Science ®Google Scholar
• Rossi AC, Hsu JP, Faich GA. Ulcerogenicity of piroxicam: an analysis of spontaneously reported data. Br Med J (Clin Res Ed) 1987; 294:147–50
   PubMed Web of Science ®Google Scholar
• Waller PC, Arlett P. Responding to signals. Pharmacovigilance, 1st edn. Mann R, Andrews E. Chichester, UK: John Wiley & Sons, 2002;105–28
   Google Scholar
• US Food and Drug Administration. Adverse Event Reporting System (AERS). Available at: http://www.fda.gov/cder/aers/default.htm [Last accessed 13 March 2008]
   Google Scholar