Safety information in drug labeling: A comparison of the USA, The UK, And Japan

Pharmacoepidemiology and Drug Safety

Volumn 22, Issue 3, 2013, Pages 306-318

  Shimazawa, Rumiko ^a   Ikeda, Masayuki ^a  

^a NAGASAKI UNIVERSITY   (Japan)

Author keywords

Drug approval; Drug labeling; Drug toxicity; Pharmacoepidemiology

Indexed keywords

ANTIBIOTIC AGENT; ANTINEOPLASTIC AGENT; BIOLOGICAL PRODUCT; DROSPIRENONE PLUS ETHINYLESTRADIOL; IMMUNOMODULATING AGENT;

ARTICLE; CARDIOVASCULAR DISEASE; CONTROLLED STUDY; CROSS-SECTIONAL STUDY; DRUG CONTRAINDICATION; DRUG INDICATION; DRUG INFORMATION; DRUG LABELING; DRUG SAFETY; HEALTH SURVEY; HEMATOLOGIC DISEASE; HUMAN; IMMUNOPATHOLOGY; JAPAN; JAPANESE; MULTICENTER STUDY; NEOPLASM; NEUROLOGIC DISEASE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROPORTION OF BOXED WARNING; PROPORTION OF CONTRAINDICATION; PROPORTION OF TOTAL SAFETY INFORMATION; QUANTITATIVE ANALYSIS; UNITED KINGDOM; UNITED STATES; UROGENITAL TRACT DISEASE;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CROSS-SECTIONAL STUDIES; DRUG AND NARCOTIC CONTROL; DRUG INDUSTRY; DRUG LABELING; DRUG THERAPY; GREAT BRITAIN; GUIDELINE ADHERENCE; GUIDELINES AS TOPIC; HUMANS; JAPAN; PATIENT SAFETY; PHARMACOEPIDEMIOLOGY; RISK ASSESSMENT; RISK FACTORS; UNITED STATES;

EID: 84874529293     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3408     Document Type: Article

References (36)

1. Davis TC, Wolf MS, Bass PF 3rd, et al. Literacy and misunderstanding prescription drug labels. Ann Intern Med 2006; 145: 887-894.
2. Woosley RL. Drug labeling revisions-guaranteed to fail? JAMA 2000; 284: 3047-3049.
3. Giezen TJ, Mantel-Teeuwisse AK, Straus SM, et al. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA 2008; 300: 1887-1896.
4. Duke J, Friedlin J, Ryan P. A quantitative analysis of adverse events and "overwarning" in drug labeling. Arch Intern Med 2011; 171: 944-946.
5. van der Sijs H, van Gelder T, Vulto A, et al. Understanding handling of drug safety alerts: a simulation study. Int J Med Inform 2010; 79: 361-369.
6. Lasser KE, Seger DL, Yu DT, et al. Adherence to black box warnings for prescription medications in outpatients. Arch Intern Med 2006; 166: 338-344.
7. Arnold FL, Kusama M, Ono S. Exploring differences in drug doses between Japan and Western countries. Clin Pharmacol Ther 2010; 87: 714-720.
8. Malinowski HJ, Westelinck A, Sato J, et al. Same drug, different dosing: differences in dosing for drugs approved in the United States, Europe, and Japan. J Clin Pharmacol 2008; 48: 900-908.
9. Pappas G, Ierodiakonou V, Falagas ME. Lost in translation: differences in antimicrobial indication approval policies between the United States and Europe. Clin Ther 2009; 31: 1595-1603.
10. Briley M. Drugs to treat fibromyalgia - the transatlantic difference. Curr Opin Investig Drugs 2010; 11: 16-18.
11. Furberg CD. Decisions by regulatory agencies: are they evidence-based? Trials 2007; 8: 13.
12. Nieminen O, Kurki P, Nordstrom K. Differences in product information of biopharmaceuticals in the EU and the USA: implications for product development. Eur J Pharm Biopharm 2005; 60: 319-326.
13. Garbe E, Andersohn F. Contraindication labelling changes in the United States and Germany. Eur J Clin Pharmacol 2007; 63: 87-93.
14. Buckley NA, Rossi S. Bringing greater transparency to "black box" warnings. Clin Toxicol (Phila) 2011; 49: 448-451.
15. Lee E, Ryan S, Birmingham B, et al. Rosuvastatin pharmacokinetics and pharmacogenetics in white and Asian subjects residing in the same environment. Clin Pharmacol Ther 2005; 78: 330-341.
16. Sato T, Inokuma S, Sagawa A, et al. Factors associated with fatal outcome of leflunomide-induced lung injury in Japanese patients with rheumatoid arthritis. Rheumatology (Oxford) 2009; 48: 1265-1268.
17. The Food and Drug Administration. 21 CFR parts 201, 314, and 601: requirements on content and format of labeling for human prescription drug and biological products. Final rule. (January 24, 2006). http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1269-nfr0001-01.pdf (accessed 10 October 2012).
18. Notice to applicants: a guideline on summary of product characteristics. http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf (accessed 10 October 2012).
19. CHAPTER 2 Pharmaceutical laws and regulations in pharmaceutical regulations in Japan. http://www.jpma.or.jp/english/parj/pdf/2012_ch02.pdf (accessed 10 October 2012).
20. Hirst C, Cook S, Dai W, et al. A call for international harmonization in therapeutic risk management. Pharmacoepidemiol Drug Saf 2006; 15: 839-849.
21. Cohen D. Insiders criticise FDA's decision not to withdraw rosiglitazone. BMJ 2010; 341: c5333.
22. FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer. http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm (accessed 10 October 2012).
23. PMDA Reviews (shinsahoukokusho). http://www.shinsahoukokusho.jp/dar_us/dar/search/usDarSearch.jsp (in Japanese) (accessed 10 October 2012).
24. DailyMed. http://dailymed.nlm.nih.gov/dailymed/about.cfm (accessed 10 October 2012).
25. The electronic Medicines Compendium. http://www.medicines.org.uk/EMC/ (accessed 10 October 2012).
26. Japanese Drug Labels. http://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html (in Japanese) (accessed 10 October 2012).
27. ATC/DDD Index 2011. http://www.whocc.no/atc_ddd_index/ (accessed 10 October 2012).
28. Drugs@FDA. http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/ (accessed 10 October 2012).
29. Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:159:0046:0094:en:PDF (accessed 10 October 2012).
30. Hirai Y, Kinoshita H, Kusama M, et al. Delays in new drug applications in Japan and industrial R&D strategies. Clin Pharmacol Ther 2010; 87: 212-218.
31. Ministry of Health and Welfare. Section 3. Promoting safety measures forpharmaceuticals. Chapter 6. Efforts for protecting health and safety and improvement of living environment. in White Paper. Annual Report on Health and Welfare. 1998-1999 Social Security and National Life. http://www1.mhlw.go.jp/english/wp_5/vol1/p2c6s3.html (accessed 10 October 2012).
32. Okuda H, Ogura K, Kato A, et al. A possible mechanism of eighteen patient deaths caused by interactions of sorivudine, a new antiviral drug, with oral 5-fluorouracil prodrugs. J Pharmacol Exp Ther 1998; 287: 791-799.
33. Inoue A, Saijo Y, Maemondo M, et al. Severe acute interstitial pneumonia and gefitinib. Lancet 2003; 361: 137-139.
34. Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems. N Engl J Med 2008; 358: 1354-1361.
35. Sinha G. Japan works to shorten "drug lag," boost trials of new drugs. J Natl Cancer Inst 2010; 102: 148-151.
36. Marshall RD, Posner K, Greenhill L. Risk perception research and the black box warning for SSRIs in children. J Am Acad Child Adolesc Psychiatry 2006; 45: 765.