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| First Reports of Adverse Drug Reactions (ADRs) In 2001 |
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Drug and ADR
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Reference
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| 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 |
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