An assessment of the publicly disseminated evidence of safety used in decisions to withdraw medicinal products from the UK and US markets

Drug Safety

Volumn 29, Issue 2, 2006, Pages 175-181

  Clarke, Andrea ^a   Deeks, Jonathan J ^b   Shakir, Saad A W ^a,c  

^a DRUG SAFETY RESEARCH UNIT   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c UNIVERSITY OF PORTSMOUTH   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALOSETRON; ASTEMIZOLE; CERIVASTATIN; CISAPRIDE; DROPERIDOL; GREPAFLOXACIN; LEVACETYLMETHADOL; PHENYLPROPANOLAMINE; PUMACTANT; RAPACURONIUM BROMIDE; TROGLITAZONE;

ARTICLE; BRONCHOSPASM; CLASSIFICATION; COMPARATIVE STUDY; CONSTIPATION; DRUG FATALITY; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; HEART ARRHYTHMIA; HEART VENTRICLE ARRHYTHMIA; HUMAN; ISCHEMIC COLITIS; LIVER TOXICITY; MEDICAL DECISION MAKING; MORTALITY; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QT PROLONGATION; RHABDOMYOLYSIS; SIDE EFFECT; STROKE; SUDDEN DEATH; TORSADE DES POINTES; UNITED KINGDOM; UNITED STATES;

CONSUMER PRODUCT SAFETY; DRUG AND NARCOTIC CONTROL; GREAT BRITAIN; HUMANS; PHARMACEUTICAL PREPARATIONS; PRESCRIPTIONS, DRUG; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES;

EID: 32244432294     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200629020-00008     Document Type: Article

References (18)

1. Carne X, Arnaiz JA. Methodological and political issues in clinical pharmacology research by the year 2000. Eur J Clin Pharmacol 2000; 55: 781-5
2. Skegg DC. Pitfalls of pharmacoepidemiology. BMJ 2000; 321: 1171-2
3. Jefferys DB, Leakey D, Lewis JA, et al. New active substances authorized in the United Kingdom between 1972 and 1994. Br J Clin Pharmacol 1998; 45: 151-6
4. Cuervo LG, Clarke M. Balancing benefits and harms in health care. BMJ 2003; 327: 65-6
5. Arnaiz JA, Carne X, Riba N, et al. The use of evidence in pharmacovigilance: case reports as the reference source for drug withdrawals. Eur J Clin Pharmacol 2001; 57: 89-91
6. US Food and Drug Administration. Safety-based drug withdrawals (1997-2001) [online]. Available from URL: http://www.fda.gov/fdac/features/2002/ chrtWithdrawals.html [Accessed 2002 Jul 25]
7. UK Medicines Control Agency (MCA) [online]. Available from URL: http://www.mca.gov [Accessed 2002 May 10]
8. European Agency for the Evaluation of Medicinal Products (EMEA) [online]. Available from URL: http://www.emea.eu.int [Accessed 2002 May 10]
9. US Food and Drug Administration [online]. Available from URL: http://www.fda.gov [Accessed 2002 Jul 25]
10. Ross-Degnan D, Soumerai SB, Fortess EE, et al. Examining product risk in context: market withdrawal of zomepirac as a case study. JAMA 1993; 270: 1937-42
11. Sackett DL, Straus ES, Richardson WS, et al. Evidence-based medicine: how to practice and teach EBM. London: Churchill Livingstone, 2000: 169-82
12. Shakir SA. PEM in the UK. In: Mann RD, Andrews EB, editors. Pharmacovigilance. Chichester: John Wiley & Sons Ltd, 2002: 333-44
13. Heeley E, Riley J, Layton D, et al. Prescription-event monitoring and reporting of adverse drug reactions. Lancet 2001; 358: 1872-3
14. Martin RM, Kapoor KV, Wilton LV, et al. Underreporting of suspected adverse drug reactions to newly marketed ('black triangle') drugs in general practice: observational study. BMJ 1998; 317: 119-20
15. Glasser DB, Dieck GS. A view from industry. In: Strom B, editor. Pharmacoepidemiology. Chichester: John Wiley & Sons Ltd, 2000: 91-108
16. Wiholm BE, Olsson S, Moore N, et al. Spontaneous reporting systems outside the US. In: Strom B, editor. Pharmacoepidemiology. Chichester: John Wiley & Sons Ltd, 2000: 175-92
17. Strom B. What is pharmacoepidemiology? In: Strom B, editor. Pharmacoepidemiology. Chichester: John Wiley & Sons, 2000: 4-15
18. Mann R. Prescription-event monitoring. In: Strom B, editor. Pharmacoepidemiology. Chichester: John Wiley & Sons, 2000: 231-46