References
- Fagin D Toxicology: The learning curve. Nature 2012;490:462–5.
- Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000;356:1255–9.
- Avorn J. The role of therapeutic agents in modern medicine, B: drug risks. In: van Boxtel CJ, Santoso B, Ralph Edwards I, editors. Drug benefits and risks – clinical pharmacology. 2nd ed. Amsterdam, Netherlands: IOS Press; 2008.
- Hannan EL. Randomized clinical trials and observational studies. JACC: Cardiovasc Interv 2008;1:211–217.
- Booth CM, Tannock IF. Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence. Br J Cancer 2014;110:551–555.
- Dans AL, Dans LF, Guyatt GH, et al. Users’ guides to the medical literature: XIV. How to decide on the applicability of clinical trial results to your patient. Evidence-Based Medicine Working Group. JAMA 1998;279:545–549.
- WHO. Glossary of terms used in Pharmacovigilance. Uppsala, Sweden. Available online at: http://who-umc.org/Graphics/24729.pdf, accessed 1 September 2015.
- The European Parliament and the Council of the European Union. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the community code relating to medicinal products for human use. Official J Eur Commun 2010:348:74–99.
- US Department of Health and Human Services. National Institute of Health. Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0, Published: May 28, 2009. Available online at: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf, accessed 12 November 2015.
- U.S. Food and Drug Administration. Regulatory Information. Federal Food and Drug Acts of 1906. US Public Law Number 59-384. 34 STAT. 768 (1906). Washington DC. Available online at: http://www.fda.gov/RegulatoryInformation/Legislation/ucm148690.htm, accessed 1 September 2015.
- Berridge V. Heroin prescription and history. N Engl J Med 2009;361:820–821.
- Geiger JC. Concerning elixir of sulfanilamide. Cal West Med 1937;47:353.
- U.S. Food and Drug Administration. The 1938 Food, Drug, and Cosmetic Act. Pub. L. No. 75-717, 52 Stat. 1040 (1938). Available online at: http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/ucm132818.htm, accessed 1 September 2015.
- Gupta A, Waldhauser LK. Adverse drug reactions from birth to early childhood. Pediatr Clin North Am 1997;44:79–92.
- Conway J, Bero L, Ondari C, et al. Review of the quality of pediatric medications in developing countries. J Pharm Sci 2013;102:1419–1433.
- Avorn J. Learning about the safety of drugs–a half-century of evolution. N Engl J Med 2011;365:2151–2153.
- Lenz W. Deformities in children after prescribed drug use during pregnancy? Dtsch Med Wochenschr 1961;86:2555.
- McBride WG. Thalidomide and congenital abnormalities. Lancet 1961;2:1358.
- FDA Milestones in U.S. Food and Drug Law History. Available online at: http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm128305.htm, accessed 1 September 2015.
- Bombardier C, Laine L, Reicin A, et al. VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med 2000;343:1520–1528.
- Gottlieb S. Researchers deny any attempt to mislead the public over JAMA article on arthritis drug. BMJ 2001;323:301.
- Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. Review. JAMA 2001;286:954–959.
- Bresalier RS, Sandler RS, Quan H, et al. Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005;352:1092–1102. Erratum in: N Engl J Med 2006;355:221.
- Graham DJ, Campen D, Hui R, et al. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 2005;365:475–481.
- McNaughton R, Huet G, Shakir S. An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making. BMJ Open 2014;4:e004221.
- Borg JJ, Tanti A, Kouvelas D, et al. European Union pharmacovigilance capabilities: potential for the new legislation. Ther Adv Drug Saf 2015;6:120–140.
- Danan G1, Benichou C.Causality assessment of adverse reactions to drugs–I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries.J Clin Epidemiol 1993;46:1323–1330.
- Karch FE, Lasagna L. Toward the operational identification of adverse drug reactions. Clin Pharmacol Ther 1977;21:247–254.
- Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239–245.
- Teschke R, Schwarzenboeck A, Hennermann KH. Causality assessment in hepatotoxicity by drugs and dietary supplements. Br J Clin Pharmacol 2008;66:758–766.
- Teschke R, Bahre R, Genthner A, et al. Suspected black cohosh hepatotoxicity–challenges and pitfalls of causality assessment. Maturitas 2009;63:302–314.
- Teschke R, Schmidt-Taenzer W, Wolff A. Spontaneous reports of assumed herbal hepatotoxicity by black cohosh: is the liver-unspecific Naranjo scale precise enough to ascertain causality? Pharmacoepidemiol Drug Saf 2011;20:567–582.
- Teschke R, Frenzel C, Schulze J, et al. Spontaneous reports of primarily suspected herbal hepatotoxicity by Pelargonium sidoides: was causality adequately ascertained? Regul Toxicol Pharmacol 2012;63:1–9.
- The European Parliament and the Council of the European Union. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official J Eur Communities 2001;311:67–128.
- The European Parliament and The Council of The European Union. Regulation (Eu) No 536/2014 Of The European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official J Eur Communities 2014;158:1–158.
- The European Parliament and the Council of the European Union. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use. Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products. Official J Eur Commun 2010;348:1–16.
- Domenech G. New European legislation on pharmacovigilance. Pharmaceut Policy Law 2011;13:7–27.
- Borg J, Aislaitner G, Pirozynski M, et al. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance. Drug Saf 2011;34:187–197.
- European Medicines Agency. Referral procedures. Available online at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000150.jsp, accessed 1 September 2015.
- EMA. Good Pharmacovigilance Practices (GVP). London, UK. 2012. Available online at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp, accessed 12 November 2015.
- MedWatch. The FDA safety information and adverse event reporting program. Silver Springs, MD, US: US Food and Drug Administration. Available online at: http://www.fda.gov/Safety/MedWatch/, accessed 12 November 2015.
- Ray WA, Stein CM. Reform of drug regulation–beyond an independent drug-safety board. N Engl J Med 2006;354:194–201.
- FDA. Regulatory information. Silver Springs, MD, US: US Food and Drug Administration; 2007. Available online at: http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm, accessed 1 September 2015.
- Fontanarosa PB, Rennie D, DeAngelis CD. Postmarketing surveillance–lack of vigilance, lack of trust. JAMA 2004;292:2647–2650.
- FDA. FDA Adverse Events Reporting System (FAERS) Electronic Submissions. Silver Springs, MD, US: US Food and Drug Administration; 2015. Available online at: http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm115894.htm, accessed 1 September 2015.
- FDA. Potential signals of serious risks/new safety information identified from the FDA Adverse Event Reporting System (FAERS). Silver Springs, MD, US: US Food and Drug Administration; 2015. Available online at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082196.htm#QuarterlyReports, accessed 12 November 2015.
- Uppsala Monitoring Centre. Pharmacovigilance. Uppsala, Sweden. Available online at: http://www.who-umc.org/DynPage.aspx?id=97218&mn1=7347&mn2=7252, accessed 1 September 2015.
- Onakpoya IJ, Heneghan CJ, Aronson JK. Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis. BMC Med 2015;13:26.
- Nissen SE, Wolski K. Rosiglitazone revisited: an updated meta-analysis of risk for myocardial infarction and cardiovascular mortality. Arch Intern Med 2010;170:1191–1201.