Pharmacy Division Ramathibodi Hospital


First Reports of Adverse Drug Reactions (ADRs) In 2001

The following table contains an overview of first published case reports of adverse drug reactions identified in the international literature in the year 2001.

Definition: serious = an event when the patient outcome is death, life-threatening, hospitalisation, disability, congenital anomaly, or requires intervention to prevent permanent impairment or damage (FDA MedWatch definition).

Drug and ADR
Alosetron: ischaemic colitis Friedel D, Thomas R, Fisher RS. Ischaemic colitis during treatment with alosetron. Gastroenterol 2001 Feb; 120: 557-60
Amfebutamone (bupropion): erythema multiforme (serious) Lineberry MTW, Peters Jr GE, Bostwick JM. Bupropion-induced erythema multiforme. Mayo Clin Proc 2001 Jun; 76: 664-6
Amoxicillin/clavulanic acid: neutrophilic fixed drug eruption Agnew Kl, Oliver GF. Neutrophilic fixed drug eruption. Aust J Dermatol 2001 Aug; 42: 200-2
Anagrelide: cardiomyopathy and congestive heart failure (serious) James CW. Anagrelide-induced cardiomyopathy. Pharmacotherapy 2000 Oct; 20: 1224-7
Antiretrovirals: tendon xanthomata with highly active antiretroviral therapy (saquinavir, ritonavir, stavudine, lamivudine) Leung N, Carpentier A, Wang J, et al. Rapid development of massive tendon xanthomata following treatment with highly active antiretroviral therapy (HAART). Diabetes 2001 Jun; 50 Suppl. 2: 452-3
Artesunate: hypersensitivity reaction (serious) Leonardi E, Gilvary G, White NJ, et al. Severe allergic reactions to oral artesunate: a report of two cases. Trans Royal Soc Trop Med Hygiene 2001 Mar-Apr; 95: 182-3
Biperiden: insomnia during drug withdrawal Hirose S. Insomnia related to biperiden withdrawal in two schizophrenic patients. Int Clin Psychopharmacol 2000 Nov; 15: 357-9
Bromazepam withdrawal: catatonia (serious) Deuschle M, Lederbogen F. Benzodiazepine withdrawal-induced catatonia. Pharmacopsychiatry 2001 Jan: 34: 41-2
Capecitabine: coronary spasm in an elderly patient (serious) Schnetzler B, Popova N, Collao Lamb C, et al. Coronary spasm induced by capecitabine. Ann Oncol 2001 May; 12: 723-4
Carbamazepine/valproic acid: cutaneous psuedolymphoma Cogrel O, Beylot-Barry M, Vergier B, et al. Sodium valproateinduced cutaneous pseudolymphoma followed by recurrence with carbamazepine. Brit J Dermatol 2001 Jun; 144: 1235-8
Cefcapene pivoxil: skin eruption Kawada A, Aragane Y, Maeda A, et al. Drug eruption induced by cefcapene pivoxil hydrochloride. Contact Dermatitis 2001 Mar; 44: 197
Celecoxib: anaphylaxis (serious) Levy MB, Fink JN. Anaphylaxis to celecoxib. Ann Allergy Asthma Immunol 2001 Jul; 87: 72-3
Celecoxib: coloured spots in the visual fields in an elderly patient Lund BC, Neiman RF. Visual disturbance associated with celecoxib. Pharmacotherapy 2001 Jan; 21: 114-5
Ciprofloxacin/piperacillin/tobramycin: ultraviolet radiation recall-like reaction Krishnan RS, Lewis AT, Kass JS et al. Ultraviolet recall-like phenomenon occurring after piperacillin, tobramycin, and ciprofloxacin therapy. J Am Acad Dermatol 2001 Jun; 44: 1045-8
Ciprofloxacin/vancomycin: linear IgA bullous dermatosis in an elderly patient Wiadrowski TP, Reid CM. Drug-induced linear IgA bullous disease following antibiotics. Austral J Dermatol 2001 Aug; 42: 196-9
Cisplatin/gemcitabine: peripheral ischaemia (first report with gemcitabine; serious) Barcelo R, Lopez-Vivanco G, Mañé JM, et al. Distal ischaemic changes related to combination chemotherapy with cisplatin and gemcitabine: description of four cases.
Ann Oncol 2000 Sep; 11: 1191-4
Citalopram overdose: neuroleptic malignant syndrome (serious) Aydin N, Anaç E, Çayköylü, et al. Neuroleptic malignant syndrome due to citalopram overdose. Can J Psychiatry 2000 Dec; 45: 941-2
Clozapine: panic disorder Bressan RA, Monteiro VBM, Dias CC. Panic disorder associated with clozapine. Am J Psychiatry 2000 Dec; 157: 2056
Diclofenac: hyperkalaemic paralysis in an elderly patient (serious) Patel P, Mandal B, Greenway MW. Hyperkalaemic quadriparesis secondary to chronic diclofenac treatment. Postgrad Med J 2001 Jan; 77: 50-1
Digoxin: interaction with concomitant cisapride leading to a decreased serum concentration of digoxin in an elderly patient (serious) Kubler PA, Pillans PI, McKay JR. Possible interaction between cisapride and digoxin. Ann Pharmacother 2001 Jan; 35: 127-8
Diltiazem: photodistributed hyperpigmentation Scherschun L, Lee MW, Lim HW. Diltiazem-associated photodistributed hyperpigmentation: a review of 4 cases. Arch Dermatol 2001 Feb; 137: 179-82
Donepezil: mumbling and stuttering in an elderly patient Amouyal-Barkate K, Bagheri-Charabiani H, Montastruc JL, et al. Abnormal movements with donepezil in Alzheimer disease. Ann Pharmacother 2000 Nov; 34: 1347
Doxycycline: hypoglycaemia in an elderly patient with type 2 diabetes mellitus (serious) Odeh M, Oliven A. Doxycycline-induced hypoglycaemia.
J Clin Pharmacol 2000 Oct; 40: 1173-4
Echinacea: erythema nodosum Soon SL, Crawford RI. Recurrent erythema nodosum associated with echinacea herbal therapy. J Am Acad Dermatol 2001 Feb;! 44: 298-9
Edodekin alfa: haemolytic anaemia and neutropenia with bone marrow agranulocytosis (serious) Gollob JA, Veenstra KG, Mier JW, et al. Agranulocytosis and hemolytic anemia in patients with renal cell cancer treated with interleukin-12. J Immunother 2001 Feb; 24: 91-8
Efavirenz: gynaecomastia Arranz Caso JA, de Miguel Prieto J, Casas E, et al. Gynecomastia without lipodystrophy syndrome in HIV-infected men treated with efavirenz. AIDS 2001 Jul; 15: 1447-8
Enalapril: hyperkalaemic paralysis in an elderly patient with mild chronic renal impairment (serious) Dutta D, Fischler M, McClung A. Angiotensin converting enzyme inhibitor induced hyperkalaemic paralysis. Postgrad Med J 2001 Feb; 77: 114-5
Enoxaparin sodium: splenic rupture (serious) Burg MD, Dallara JJ. Rupture of previously normal spleen in association with enoxaparin: an unusual cause of shock. J Emerg Med 2001 May; 20: 349-52
Ephedra (herbal medicine): myocardial infarction (serious) Traub SJ, Hoyek W, Hoffman RS. Dietary supplements containing ephedra alkaloids. New Eng J Med 2001 Apr; 344: 1096
Etanercept: hyperthyroidism Allanore Y, Brémont C, Kahan A, et al. Transient hyperthyroidism in a patient with rheumatoid arthritis treated with etanercept. Clin Exp Rheum 2001 May-Jun; 19: 356-7
Etanercept: pneumococcal sepsis (serious) Baghai M, Osmon DR, Wolk DM, et al. Fatal sepsis in a patient with rheumatoid arthritis treated by etanercept. Mayo Clin Proc 2001 Jun; 76: 653-6
Etanercept: type 1 diabetes mellitus in a child (serious) Bloom BJ. Development of diabetes mellitus during etanercept therapy in a child with systemic-onset juvenile rheumatoid arthritis. Arthritis Rheum 2000 Nov; 43: 2606-8
Fentanyl: explosive cough and periorbital purpuric rash in a child Tweed WA, Dakin D. Explosive coughing after bolus fentanyl injection. Anesth Analg 2001 Jun; 92: 1442-3
Fluticasone propionate: intracranial hypertension (serious) Bond DW, Charlton CPJ, Gregson, RM. Benign intracranial hypertension secondary to nasal fluticasone propionate. BMJ 2001 Apr; 322: 897
Gatifloxacin: QTc prolongation and ventricular tachycardia in an elderly patient (serious) Iannini PB, Circiumaru I. Gatifloxacin-induced QTc prolongation and ventricular tachycardia. Pharmacother 2001 Mar; 21: 361-362
Glucagon: thrombocytopenia and hyponatraemia with seizures in a premature neonate (serious) Belik J, Musey J, Trussell RA. Continuous infusion of glucagon induces severe hyponatremia and thrombocytopenia in a premature neonate. Pediatrics 2001 Mar; 107: 595-7
Hyaluronan/methylprednisolone: pulmonary embolism in an elderly patient (serious) Famularo G, Liberati C, Sebastiani GD, et al. Pulmonary embolism after intra-articular injection of methylprednisolone and hyaluronate. Clin Exp Rheum 2001 May-Jun; 19: 355
Hypericum: alopecia Parker V, Wong AHC, Boon HS, et al. Adverse reactions to St. John's wort. Can J Psychiatry 2001 Feb; 46: 77-9
Infliximab: fatal aspergillosis (serious) Warris A, Bjorneklett A, Gaustd P. Invasive pulmonary aspergillosis associated with infliximab therapy. New Eng J Med 2001 Apr; 344: 1099-1100
Interferon-B/ribavirin: osteoporosis (serious) Solas-Herruzo JA, Castellano G, Fernandez I, et al. Decreased bone mineral density after therapy with alpha interferon in combination with ribavirin for chronic hepatitis C. J Hepatol 2000 Nov; 33: 812-7
Interferon-B: nephrotic syndrome (serious) Gotsman I, Elhallel-Darnitski M, Friedlander Z, et al. B-Interferon-induced nephrotic syndrome in a patient with multiple sclerosis. Clin Nephrol 2000 Nov; 54: 425-6
Leflunomide/methotrexate: cirrhosis (first report with leflunomide; serious) Weinblatt ME, Dixon JA, Falchuk KR. Serious liver disease in a patient receiving methotrexate and leflunomide. Arthritis Rheum 2000 Nov; 43: 2609-11
Leuprorelin: fibromyalgia (serious) Toussirot E, Wendling D. Fibromyalgia developed after administration of gonadotrophin-releasing hormone analogue. Clin Rheum 2001; 20: 150-2
Lithium: follicular mycosis fungoides Francis GJ, Silverman AR, Saleh O, et al. Follicular mycosis fungoides associated with lithium. J Am Acad Dermatol 2001 Feb; 44: 308-9
Lithium: interaction with concomitant levofloxacin leading to renal failure and neurological disorders Takahashi H, Higuchi H, Shimizu T. Severe lithium toxicity induced by combined levofloxacin administration. J Clin Psychiatry 2000 Dec; 61: 949-50
Meloxicam: ischaemic colitis (serious) Garcia B, Ramaholimihaso F, Diebold M-D, et al. Ischaemic colitis in a patient taking meloxicam. Lancet 2001 Mar 3; 357: 690
Methylphenidate: bodyweight loss Chandramouli JB, Muller BA. Case report of severe weight loss possibly associated with methylphenidate. J Pharmacy Technology 2000 Sep-Oct; 16: 197-201
Mifepristone: endometrial hyperplasia in a child Newfield RS, Spitz IM, Isacson C, et al. Long-term mifepristone (RU486) therapy resulting in massive benign endometrial hyperplasia. Clin Endo 2001 Mar; 54: 399-404
Mirtazapine: pancreatitis Sommer M, Dieterich A, Krause C, et al. Subclinical pancreatitis related to mirtazapine - a case report. Pharmacopsych 2001 Jul; 34: 158-9
Mycophenolate mofetil: deep vein thrombosis (serious) Cherney DZI, Zaltzman JS. Mycophenolate mofetil causing deep venous thrombosis in a renal transplant patient with factor V leiden. Neph Dial Transp 2001 Aug; 16: 1702-4
Mycophenolate mofetil: hyperbilirubinaemia Chueh S-C, Huang C-Y, Lai M-K. Mycophenolate mofetil-induced hyperbilirubinaemia in renal transplant recipients. Transplantation Proceedings 2000 Nov; 32: 1901-2
Mycophenolate mofetil: ischaemic colitis (serious) Kim HC, Park SB. Mycophenolate mofetil-induced ischaemic colitis. Transplantation Proceedings 2000 Nov; 32: 1896-7
Nadroparin calcium/enoxaparin sodium: liver disorders Hui C-K, Yuen M-F, Ng IO-L, et al. Low molecular weight heparininduced liver toxicity. J Clin Pharmacol 2001 Jun; 41: 691-4
Nortriptyline: interaction with concomitant amfebuta- mone (bupropion) leading to confusion and lethargy in an elderly patient Weintraub D. Nortriptyline toxicity secondary to interaction with bupropion sustained-release. Depress Anxiety 2001; 13 (1): 50-2
Ofloxacin: diabetes insipidus Bharani A, Kumar H. Diabetes insipidus induced by ofloxacin. BMJ2001 Sep; 323: 547
Olanzapine: hypersensitivity syndrome (serious) Raz A, Bergman R, Eilam O, et al. A case-report of olanzapine-induced hypersensitivity syndrome. Am J Med Sci 2001 Feb; 321: 156-8
Ondansetron/paracetamol/tropisetron: fixed drug eruption in a patient receiving interleukin-2 therapy (first report with tropisetron) Bernand S, Scheidegger EP, Dummer R, et al. Multifocal fixed drug eruption to paracetamol, tropisetron and ondansetron induced by interleukin 2. Dermatology 2000; 210 (2): 148-50
Orlistat: hyperglycemia and diabetic ketoacidosis in a patient with type 1 diabetes mellitus (serious) Azar ST, Zantout MS. Diabetic ketoacidosis associated with orlistat treatment. Diabetes Care 2001 Mar; 24: 602
Orlistat: liver failure (serious) Montero JL, Muntané J, Fraga E, et al. Orlistat associated subacute hepatic failure. J Hepatol 2001 Jan; 34: 173
Ornidazole: autoimmune hepatitis Kosar Y, Sasmaz N, Oguz P, et al. Ornidazole-induced autoimmune hepatitis. Eur J Gastro Hep 2001 Jun; 13: 737-9
Oxybuprocaine: allergic contact dermatitis following ophthalmic administration Blaschke V, Fuchs T. Periorbital allergic contact dermatitis from oxybuprocaine. Contact Dermatitis 2001 Mar; 44: 198
Paclitaxel/trastuzumab: photosensitivity Mermershtain W, Cohen AD, Geffen DB, et al. Cutaneous photosensitivity associated with abberations in the heme biosynthetic pathway induced by taxanes and trastuzumab: a report of 3 cases of metastatic breast cancer [abstract]. Ann Oncol 2000; 11 Suppl. 4: 28
Paroxetine: cutaneous vasculitis Margolese HC, Chouinard G, Beauclair L, et al. Cutaneous vasculitis induced by paroxetine. Am J Psychiatry 2001 Mar;! 158: 497
Phenytoin: interaction with concomitant capecitabine leading to brain disorders Schaller G, Ebert A, Kuhle A, et al. Drug interaction of capecitabine and phenytoin in the therapy of cerebral and visceral metastatic breast cancer [abstract]. Ann Oncol 2000; 11 Suppl. 4: 139
Quetiapine: hypomania Benazzi F. Quetiapine-associated hypomania in a women with schizoaffective disorder. Can J Pyschiatr 2001 Mar; 46: 182-183
Quinapril: pemphigus vulgaris Ong CS, Cook N, Lee S. Drug-related pemphigus and angiotensin converting enzyme inhibitors. Aust J Dermatol 2000 Nov; 41: 242-6
Rabeprazole/terbinafine: acute fulminant hepatitis (serious) Johnstone D, Berger C, Fleckman P. Acute fulminant hepatitis after treatment with rabeprazole and terbinafine. Arch Intern Med 2001 Jul; 161: 1677-8
Reboxetine: interaction with concomitant fluoxetine leading to urinary retention and other anticholinergic effects Benazzi F. Urinary retention with reboxetine-fluoxetine combination in a young man. Can J Psychiatry 2000 Dec; 45: 936
Rituximab: serum sickness (serious) D'Arcy CA, Mannik M. Serum sickness secondary to treatment with the murine-human chimeric antibody IDEC-C2B8 (rituximab). Arth Rheum 2001 Jul; 44: 1717-8
Ropivacaine: diplopia Wells AP, Maslin K. Diplopia from peribulbar ropivacaine. Clin Exper Opthamol 2000 Feb; 28: 32-3
Rosiglitazone/troglitazone: pulmonary and peripheral oedema in the elderly (serious) Thomas ML, Lloyd SJ. Pulmonary edema associated with rosiglitazone and troglitazone. Ann Pharmacother 2001 Jan; 35: 123-4
Serenoa repens: perioperative haemorrhage (serious) Cheema P, El-Mefty O, Jazieh AR. Intraoperative haemorrhage associated with the use of extract of saw palmetto herb: a case report and review of literature. J Int Med 2001 Aug; 250: 167-9
Sertraline overdose: asthma (serious) Carson HJ, Zweigart M, Lueck NE. Death from asthma associated with sertraline overdose. Am J Forensic Med Pathol 2000 Sep; 21: 273-5
Sildenafil: interaction with concomitant diltiazem leading to nitroglycerin-induced hypotension in an elderly patient Khoury V, Kritharides L. Diltiazem-mediated inhibition of sildenafil metabolism may promote nitrate-induced hypotension. Aust N Z J Med 2000 Oct; 30: 641-2
Tacrolimus: interaction with concomitant fluconazole leading to leucocyte disorders Gondo H, Okamura C, Osaki K, et al. Acquired Pelger-Huët anomaly in association with concomitant tacrolimus and fluconazole therapy following allogeneic bone marrow transplantation. Bone Marrow Transplantation 2000 Dec; 26 (11): 1255-7
Tiapride: torsade de pointes in an elderly patient Iglesias E, Esteban E, Zabala S, et al. Tiapride-induced torsade de pointes. Am J Med 2000 Oct 15; 109: 509
Triazolam: interaction with concomitant rifampicin leading to insomnia in an elderly patient Tanigawa M, Odo S, Kinjyo M, et al. Rifampicin influenced effects of triazolam in an outpatient with schizophrenic disorder [abstract]. Int Clin Psychopharmacol 2000 Nov; 15: 369
Trovafloxacin: leucopenia in an elderly patient Mitropoulos FA, Angood PB, Rabinovici R. Trovafloxacin-associated leukopenia. Ann Pharmacother 2001 Jan; 35: 41-4
Warfarin: interaction with concomitant levonorgestrel leading to an elevated international normalised ratio Ellison J, Thomson AJ, Greer IA, et al. Apparent iteration between warfarin and levonorgestrel used for emergency contraception. BMJ 2000 Dec 2; 321: 1382
Warfarin: interaction with concomitant nevirapine lead- ing to coagulation disorders Dionisio D, Mininni S, Bartolozzi D, et al. Need for increased dose of warfarin in HIV patients taking nevirapine. AIDS 2001 Jan 26; 15: 277-8
Warfarin: interaction with concomitant sulfasalazine leading to warfarin resistance (serious) Teefy AM, Martin JE, Kovacs MJ. Warfarin resistance due to sulfasalazine. Ann Pharmacother 2000 Nov; 34: 1265-8

Back To Top © 2001-2009 RxRama ---- All rights reserved.