Case series in drug safety: A review to determine characteristics and quality

Drug Safety

Volumn 33, Issue 12, 2010, Pages 1081-1088

  Abou Chakra, Claire Nour ^a   Pariente, Antoine ^a,b   Pinet, Marion ^a,b   Nkeng, Lenhangmbong ^a   Moore, Nicholas ^b   Moride, Yola ^a,c  

^a UNIVERSITÉ DE MONTRÉAL   (Canada)

^b UNIVERSITÉ DE BORDEAUX   (France)

^c CENTRE HOSPITALIER DE L UNIVERSITÉ DE MONTRÉAL   (Canada)

Author keywords

Adverse drug reactions; Guideline utilisation; Pharmacovigilance; Postmarketing surveillance.

Indexed keywords

ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; BISPHOSPHONIC ACID DERIVATIVE; CENTRAL NERVOUS SYSTEM AGENTS; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; IMMUNOMODULATING AGENT; INFLIXIMAB; LEFLUNOMIDE;

CARDIOVASCULAR SYSTEM; CASE REPORT; COMORBIDITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HUMAN; NERVOUS SYSTEM; PRIORITY JOURNAL; REVIEW; SKIN;

DRUG TOXICITY; HUMANS; PHARMACOEPIDEMIOLOGY; PRACTICE GUIDELINES AS TOPIC; PUBLISHING; QUALITY CONTROL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 78549263766     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11539300-000000000-00000     Document Type: Review

References (33)

1. McBride W. Thalidomide and congenital abnormalities [letter]. The Lancet 1961; 278 (7216): 1358
2. 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
3. Olivier P, Montastruc JL. The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France. Pharmacoepidemiol Drug Saf 2006; 15: 808-12
4. Lexchin J. Drug withdrawals from the Canadian market for safety reasons, 1963-2004. CMAJ 2005; 172: 765-7
5. Auriche M, Bertrand P, Blay N, et al. Good practices of publication of clinical cases of pharmacovigilance: comments, Groupe de Travail sur les Bonnes Pratiques de Publication de Cliniques en Pharmacovigilance: commentary. Therapie 1997 Mar-Apr; 52 (2): 123-7
6. FDA. Guidance for industry: good pharmacovigilance practices and pharmacoepidemiologic assessment [online]. Available from URL http://www fda.gov/downloads/ RegulatoryInformation/Guidances/UCM126834.pdf [Accessed 2010 Jul 30]
7. Kelly W, Arellano F, Barnes J, et al. Guidelines for submitting adverse event reports for publication. Therapie 2009 Jul-Aug; 64 (4): 289-94
8. Kelly WN, Arellano FM, Barnes J, et al. Guidelines for submitting adverse event reports for publication. Pharma-coepidemiol Drug Saf 2007 May; 16 (5): 581-7
9. Kelly WN, Arellano FM, Barnes J, et al. Guidelines for submitting adverse event reports for publication. Drug Saf 2007; 30 (5): 367-73
10. World Health Organization. International classification of diseases (ICD), 10th ed. [online]. Available from URL http://www.who.int/classifications/ icd/en/ [Accessed 2010 Sep 9].
11. Kwon HJ, Cote TR, Cuffe MS, et al. Case reports of heart failure after therapy with a tumor necrosis factor antagonist. Ann Intern Med 2003; 138: 807-11
12. Botsios C, Ostuni P, Todesco S. Frequenza e trattamento delle reazioni all'infusione di infliximab in 186 pazienti con artrite reumatoide: esperienza di Padova. Reumatismo 2005; 57: 44-51
13. Rajaraman RT, Kimura Y, Li S, et al. Retrospective case review of pediatric patients with uveitis treated with in-fliximab. Ophthalmology 2006; 113: 308-14
14. Merino G, Varas G, Diaz G, et al. Eficacia del infliximab en pacientes con sindrome de Behcet portadores de uveo-retinitis grave. Rev Med Chil 2006; 134: 875-82
15. Scollard DM, Joyce MP, Gillis TP. Development of leprosy and type 1 leprosy reactions after treatment with inflixi-mab: a report of 2 cases. Clin Infect Dis 2006; 43: e19-22
16. Fardet L, Dupuy A, Kerob D, et al. Infliximab for severe hidradenitis suppurativa: transient clinical efficacy in 7 consecutive patients. J Am Acad Dermatol 2007; 56: 624-8
17. Severs GA, Lawlor TH, Purcell SM, et al. Cutaneous adverse reaction to infliximab: report of psoriasis developing in 3 patients. Cutis 2007; 80: 231-7
18. Wegscheider BJ, El-Shabrawi L, Weger M, et al. Adverse skin reactions to infliximab in the treatment of intraocular inflammation. Eye 2007; 21: 547-9
19. Fraunfelder FW. Ocular hemorrhage possibly the result of HMG-CoA reductase inhibitors. J Ocul Pharmacol Ther 2004; 20: 179-82
20. Carvajal A, Macias D, Sainz M, et al. HMG CoA reductase inhibitors and impotence: two case series from the Spanish and French drug monitoring systems. Drug Saf 2006; 29: 143-9
21. Fraunfelder FW, Richards AB. Diplopia, blepharoptosis, and ophthalmoplegia and 3-hydroxy-3-methyl-glutaryl-CoA re-ductase inhibitor use. Ophthalmology 2008; 115: 2282-5
22. Tuccori M, Lapi F, Testi A, et al. Statin-associated psychiatric adverse events: a case/non-case evaluation of an Italian database of spontaneous adverse drug reaction reporting. Drug Saf 2008; 31: 1115-23
23. Marques S, Milpied B, Foulc P, et al. Toxidermies graves au celecoxib (Celebrex). Ann Dermatol Venereol 2003; 130: 1051-5 24.
24. Brinker A, Goldkind L, Bonnel R, et al. Spontaneous reports of hypertension leading to hospitalisation in association with rofecoxib, celecoxib, nabumetone and oxaprozin. Drugs Aging 2004; 21: 479-84
25. Kidon MI, Kang LW, Chin CW, et al. Early presentation with angioedema and urticaria in cross-reactive hyper-sensitivity to nonsteroidal antiinflammatory drugs among young, Asian, atopic children. Pediatrics 2005; 116: e675-80
26. Layton D, Marshall V, Boshier A, et al. Serious skin reactions and selective COX-2 inhibitors: a case series from prescription-event monitoring in England. Drug Saf 2006; 29: 687-96
27. Savage RL, Highton J, Boyd IW, et al. Pneumonitis associated with leflunomide: a profile of New Zealand and Australian reports. Intern Med J 2006; 36: 162-9
28. Shastri V, Betkerur J, Kushalappa PA, et al. Severe cutaneous adverse drug reaction to leflunomide: a report of five cases. Indian J Dermatol Venereol Leprol 2006; 72: 286-9
29. JianX, Guo G, Ruan Y, et al. Severe cutaneous adverse drug reaction to leflunomide: a report of two cases. Cutan Ocul Toxicol 2008; 27: 5-9
30. Marunick M, Miller R, Gordon S. Adverse oral sequelae to bisphosphonate administration. J Mich Dent Assoc 2005; 87: 44-9
31. Gwynne Jones DP, Savage RL, Highton J. Alendronateinduced synovitis. J Rheumatol 2008; 35: 537-8
32. Grosso A, Douglas I, Hingorani A, et al. Post-marketing assessment of the safety of strontium ranelate; a novel case-only approach to the early detection of adverse drug reactions. Br J Clin Pharmacol 2008; 66: 689-94
33. Kelly WN, Arellano FM, Barnes J, et al. Guidelines for submitting adverse event reports for publication. Drug Saf 2007; 30: 367-73