A strategy for regulatory action when new adverse effects of a licensed product emerge

Drug Safety

Volumn 32, Issue 2, 2009, Pages 91-98

  Aronson, Jeffrey K ^a   Price, Deirdre ^a   Ferner, Robin E ^b  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b CITY HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; ADRENALIN; ALOSETRON; AZAPROPAZONE; BROMFENAC; CHLORAMPHENICOL; CISAPRIDE; CLOZAPINE; CYCLOPHOSPHAMIDE; DEXTROPROPOXYPHENE PLUS PARACETAMOL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ETOMIDATE; HYDROCORTISONE; ISOTRETINOIN; MERCAPTOPURINE; METHYLDOPA; SULFONAMIDE; THALIDOMIDE; VANCOMYCIN; WARFARIN;

ADVERSE DRUG REACTION; ANAPHYLAXIS; APLASTIC ANEMIA; BLADDER CANCER; BLEEDING; BLOOD CELL COUNT; BLOOD PRESSURE MEASUREMENT; BONE MARROW SUPPRESSION; CLINICAL DECISION MAKING; COLITIS; COLON ISCHEMIA; COST EFFECTIVENESS ANALYSIS; CYSTITIS; DRUG DESIGN; DRUG INFORMATION; DRUG MARKETING; DRUG MONITORING; DRUG SENSITIVITY; DRUG SURVEILLANCE PROGRAM; ELECTROCARDIOGRAPHY MONITORING; FOOD AND DRUG ADMINISTRATION; GASTROESOPHAGEAL REFLUX; GASTROINTESTINAL HEMORRHAGE; HEART ARRHYTHMIA; HEMOLYTIC ANEMIA; HUMAN; HYDROCORTISONE BLOOD LEVEL; HYPOTENSION; INTERNATIONAL NORMALIZED RATIO; LEUKOCYTE COUNT; LICENCE; LIVER FUNCTION TEST; LIVER INJURY; NEUTROPENIA; PRIORITY JOURNAL; RED MAN SYNDROME; RESPIRATION DEPRESSION; REVIEW; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SIDE EFFECT; SKIN ALLERGY; STEROIDOGENESIS; STEVENS JOHNSON SYNDROME; TERATOGENICITY; TORSADE DES POINTES;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG MONITORING; HUMANS; LEGISLATION, DRUG; LICENSURE; PHARMACEUTICAL PREPARATIONS;

EID: 60749130067     PISSN: 01145916     EISSN: None     Source Type: Journal    
DOI: 10.2165/00002018-200932020-00002     Document Type: Review

References (22)

1. Commission on Human Medicines [online]. Available from URL: http://www.mhra.gov.uk/home/idcplg?IdcService=SS-GET-PAGE&nodeId=863 [Accessed 2008 Jun 10]
2. US Food and Drug Administration. FDA's Mission Statement [online]. Available from URL: http://www.fda.gov/opacom/morechoices/mission.html [Accessed 2008 Jun 10]
3. O'Brien BJ, Elswood J, Calin A. Willingness to accept risk in the treatment of rheumatic disease. J Epidemiol Commun Health 1990; 44: 249-52
4. Aronson JK, Ferner RE. Joining the DoTS: new approach to classifying adverse drug reactions. BMJ 2003; 327: 1222-5
5. Glasziou P, Irwig L, Mant D. Monitoring in chronic disease: a rational approach. BMJ 2005; 330: 644-8
6. Coleman JJ, Ferner RE, Aronson JK. Monitoring for the adverse effects of drugs. In: Glasziou P, Irwig L, Aronson JK, editors. Evidence-based medical monitoring: from principles to practice. Oxford: Wiley-Blackwell, 2008: 194-210
7. Coleman JJ, Ferner RE, Evans SJW. Monitoring for adverse drug reactions. Br J Clin Pharmacol 2006; 61: 371-8
8. Aronson JK, Ferner RE. Clarification of terminology in drug safety. Drug Saf 2005; 28: 851-70
9. Aronson JK. Monitoring for harms of therapy. Br J Clin Pharmacol 2006; 61 (4): 365-6
10. Alvir JM, Lieberman JA, Safferman AZ, et al. Clozapine-induced agranulocytosis: incidence and risk factors in the United States. N Engl J Med 1993; 329: 162-7
11. Pearce SH. Spontaneous reporting of adverse reactions to carbimazole and propylthiouracil in the UK. Clin Endocrinol 2004; 61: 589-94
12. Sudarshan MK, Kodandaram NS, Venkatesh GM, et al. Evaluation of a new premedication protocol for administration of equine rabies immunoglobulin in patients with hypersensitivity. Indian J Public Health 2007; 51: 91-6
13. Loke YK. Assessing the benefit-harm balance at the bedside. BMJ 2004; 329 (7456): 7-8
14. Greenhalgh T, Kostopoulou O, Harries C. Making decisions about benefits and harms of medicines. BMJ 2004; 329 (7456): 47-50
15. Mann RD.Multi-criteria decision analysis: a new approach to an old problem. Pharmacoepidemiol Drug Saf 2007; 16 Suppl. 1: S1
16. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation applications of medicinal products for human use. March 2008 [online]. Available from URL: http://www.emea.europa.eu/ pdfs/human/brmethods/1540407enfin.pdf [Accessed 2008 Jun 10]
17. Aronson JK. Risk perception in drug therapy. Br J Clin Pharmacol 2006; 62 (2): 135-7
18. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Final concept paper. E2E: pharmaco-vigilance planning. Dated and endorsed by the Steering Committee on 11 September 2002 [online]. Available from URL: http://www.ich.org/LOB/media/ MEDIA3564.pdf [Accessed 2008 Jun 10]
19. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for industry. Development and use of risk minimization action plans. March 2005 [online]. Available from URL: http://www.fda.gov/cder/Guidance/6358fnl.htm [Accessed 2008 Jun 10]
20. European Medicines Agency. Volume 9A of the rules governing medicinal products in the European Union. Guidelines on pharmacovigilance for medicinal products for human use [online]. Available from URL: http:// ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-9/pdf/ vol9-2007-07-upd07. pdf [Accessed 2008 Jun 10]
21. US Department of Health and Human Services, Food and Drug Administration. Prescription Drug User Fee Act (PDUFA) IV. Drug safety five-year plan. March 2008 [online]. Available from URL: http://www.fda.gov/cder/pdufa/PDUFA-IV-5yr- plan-draft.pdf [Accessed 2008 Jun 10]
22. Tsintis P, La Mache E. CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications. Drug Saf 2004; 27 (8): 509-17