Why are there deadly drugs?

BMC Medicine

Volumn 13, Issue 1, 2014, Pages

  Lexchin, Joel ^a,b,c  

^a YORK UNIVERSITY   (Canada)

^b UNIVERSITY HEALTH NETWORK   (Canada)

^c UNIVERSITY OF TORONTO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ADVERSE DRUG REACTION; DRUG CONTROL; DRUG INDUSTRY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HUMAN; NOTE; PHASE 3 CLINICAL TRIAL (TOPIC); PULMONARY HYPERTENSION;

HUMANS;

EID: 84924276008     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/s12916-015-0270-2     Document Type: Note

References (20)

1. Onakpoya I, Heneghan C, Aronson J. Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis. BMC Medicine 2015.
2. Friedman M, Woodcock J, Lumpkin M, Shuren J, Hass A, Thompson L. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA. 1999;281:1728-34.
3. World Health Organization. The world medicines situation report. Geneva: WHO; 2004.
4. Pal S, Dodoo A, Mantel A, Olsson S. The world medicines situation 2011: pharmacovigilance and safety of medicines. Geneva: WHO; 2011.
5. Kamal-Yanni M, Saunders P. Urgent need for WHO's reform to prioritise core functions. Lancet. 2012;379:1878.
6. Lurie P, Wofle SM. Misleading data analyses in salmeterol (SMART) study. Lancet. 2005;366:1261-2.
7. Psaty BM, Kronmal RA. Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation. JAMA. 2008;299:1813-7.
8. Woloshin S, Schwartz L. Bringing the FDA's information to market. Arch Intern Med. 2009;169:1985-7.
9. Habibi R, Lexchin J. Quality and quantity of information in summary basis of decision documents issued by health Canada. PLoS One. 2014;9:e92038.
10. Barbui C, Baschirotto C, Cipriani A. EMA must improve the quality of its clinical trial reports. BMJ. 2011;342:d2291.
11. Carpenter D, Zucker E, Avorn J. Drug-review deadlines and safety problems. New Engl J Med. 2008;358:1354-61.
12. Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Arch Intern Med. 2012;172:1680-1.
13. Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009;169:1756-61.
14. Breau R, Gaboury I, Scales C, Fesperman S, Watterson J, Dahm P. Reporting of harm in randomized controlled trials published in the urological literature. J Urol. 2010;183:1693-7.
15. Hazell L, Shakir S. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29:385-96.
16. Mittmann N, Knowles S, Gomez M, Fish J, Cartotto R, Shear N. Evaluation of the extent of under-reporting of serious adverse drug reactions: the case of toxic epidermal necrolysis. Drug Saf. 2004;27:477-87.
17. Moore T, Cohen M, Furberg C. Serious adverse drug events reported to the Food and Drug Administration, 1998-2005. Arch Intern Med. 2007;167:1752-9.
18. Mundy A. Dispensing with the truth: the victims, the drug companies, and the dramatic story behind the battle over fen-phen. New York: St. Martin's Press; 2001.
19. Wiktorowicz M, Lexchin J, Moscou K, Silversides A, Eggertson L. Keeping an eye on prescription drugs, keeping Canadians safe: active monitoring systems for drug safety and effectiveness in Canada and internationally. Toronto: Health Council of Canada; 2010.
20. Carpenter D. Reputation and power: organizational image and pharmaceutical regulation at the FDA. Princeton University Press: Princeton; 2010.