The FDA acetaminophen Advisory Committee meeting what is the future of acetaminophen in the United States the perspective of a committee member Future of APAP in the United States

Clinical Toxicology

Volumn 47, Issue 8, 2009, Pages 784-789

  Krenzelok, Edward P ^a  

^a UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

Author keywords

Acetaminophen; Food and Drug Administration; Paracetamol

Indexed keywords

PARACETAMOL;

DRUG DOSE REDUCTION; DRUG OVERDOSE; DRUG PACKAGING; FOOD AND DRUG ADMINISTRATION; HUMAN; MORBIDITY; MORTALITY; NOTE; ORGANIZATION AND MANAGEMENT; PRESCRIPTION; RISK ASSESSMENT; UNITED STATES;

ACETAMINOPHEN; ADVISORY COMMITTEES; ANALGESICS, NON-NARCOTIC; CONGRESSES AS TOPIC; CONSUMER PRODUCT SAFETY; DRUG APPROVAL; DRUG COMBINATIONS; DRUG COMPOUNDING; DRUG LABELING; EVIDENCE-BASED MEDICINE; GOVERNMENT REGULATION; HUMANS; NONPRESCRIPTION DRUGS; OVERDOSE; PRACTICE GUIDELINES AS TOPIC; PRESCRIPTION DRUGS; RISK ASSESSMENT; UNITED STATES;

EID: 70350380082     PISSN: 15563650     EISSN: 15569519     Source Type: Journal    
DOI: 10.1080/15563650903232345     Document Type: Note

References (21)

1. Larson AM, Fontana RJ, Davern TJ, Polson J, Lalani EK, Hynan LS, Reisch JS, Shakil OA, Schiødt FV, Ostapowicz GA, Lee WM, and the ALFSG. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology 2005; 42:1367-1372.
2. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ucm126014.htm. Accessed 14 July 2009.
3. Watkins PB, Kaplowitz N, Slattery JT, Colonese CR, Colucci SV, Stewart PW, Harris SC. Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily: a randomized controlled trial. J Am Med Assoc 2006; 29:687-693.
4. Den Hertog HM, Van Der Worp HB, Van Gemert HMA, Algra A, Van Gijn J, Koudstaal PJ, Dippel DWJ. The paracetamol (acetaminophen) in stroke (PAIS) trial: a multicentre, randomized, placebo-controlled, phase III trial. Lancet Neurol 2009; 8:434-440.
5. Temple AR, Benson GD, Zinsenheim JR, Schweinle JE. Multicenter, randomized, double-blind, active-controlled, parallel-group trial of the long-term (6-12 months) safety of acetaminophen in adult patients with osteoarthritis. Clin Ther 2006; 28:222-235.
6. Dart RC, Bailey E. Does therapeutic use of acetaminophen cause acute liver failure? Pharmacotherapy 2007; 27:1219-1230.
7. Hawton K, Townsend E, Deeks J, Appleby L, Gunnell D, Bennewith O, Cooper J. Effects of legislation restricting pack sizes of paracetamol and salicylate on self poisoning in the United Kingdom: before and after study. BMJ 2001; 322:1-7.
8. Hawkins LC, Edwards JN, Dargan PL. Impact of restricting pack sizes on paracetamol poisoning in the United Kingdom. Drug Safe 2007; 30:465-479.
9. Sheen CL, Dillon JF, Bateman DN, Simpson KJ, MacDonald TM. Paracetamol-related deaths in Scotland, 1994-2000. Br J Clin Pharmacol 2002; 54:430-432.
10. Bateman DN, Gorman DR, Bain M, Inglis JHC, House FR, Murphy D. Legislation restricting paracetamol sales and patterns of self-harm and death from paracetamol-containing preparations in Scotland. Br J Clin Pharmacol 2006; 62:573-581.
11. Bateman DN. Limiting paracetamol pack size: has it worked in the UK? Clin Toxicol 2009; 47:536-541.
12. Lai MW, Klein-Schwartz W, Rodgers GC, Abrams JY, Haber DA, Bronstein AC, Wruk KM. 2005 annual report of the American Association of Poison Control Centers toxic exposure surveillance system. Am J Emerg Med 2006; 24:803-932.
13. Bronstein AC, Spyker DA, Cantilena LR, Green J, Rumack BH, Heard SE. 2007 annual report of the American Association Of Poison Control Centers national poison data system (NPDS): 25th annual report. Clin Toxicol 2008; 46:927-1057.
14. Litovitz TL, Klein-Schwartz W, White S, Cobaugh DJ, Youniss J, Omslaer JC, Drab A, Benson BE. 2000 annual report of the American Association Of Poison Control Centers toxic exposure surveillance system. Am J Emerg Med 2001; 19:337-395.
15. Litovitz TL, Klein-Schwartz W, Rodgers GC, Youniss J, Omslaer JC, May ME, Woolf AD, Benson BE. 2001 Annual report of the American Association Of Poison Control Centers toxic exposure surveillance system. Am J Emerg Med 2002; 20:391-452.
16. Watson WA, Litovitz TL, Rodgers GC, Klein-Schwartz W, Youniss J, Rutherfoord SR, Borys D, May ME. 2002 annual report of the American Association of Poison Control Centers toxic exposure surveillance system. Am J Emerg Med 2003; 21:353-421.
17. Watson WA, Litovitz TL, Rodgers GC, Klein-Schwartz W, Youniss J, Reid N, Rouse WG, Rembert RS, Borys D. 2003 annual report of the American Association of Poison Control Centers toxic exposure surveillance system. Am J Emerg Med 2004; 22:335-404.
18. Watson WA, Litovitz TL, Rodgers GC, Klein-Schwartz W, Reid N, Youniss J, Flanagan A, Wruk KM. 2004 annual report of the American Association of Poison Control Centers toxic exposure surveillance system. Am J Emerg Med 2005; 23:589-666.
19. Bronstein AC, Spyker DA, Cantilena LR, Green J, Rumack BH, Heard SE. 2006 annual report of the American Association of Poison Control Centers national poison data system (NPDS). Clin Toxicol 2007; 45:815-917.
20. http://www.cdc.gov/HomeAndRecreationalSafety/Poisoning/ prescription-overdose.html. Accessed 17 July 2009.
21. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr =1308.12. Accessed 17 July 2009.