First reports of adverse drug reactions (ADRs) in recent weeks

Drug and ADR Reference

Acarbose: acute generalised exanthematouspustulosis (serious)

Poszepczynska-Guigné E, Viguier M, Assier H, et al. Pustulose exanthématique aiguëgénéralisée induite par des médicaments à faible absorption intestinale: l’acarbose et lanystatine. Ann Dermatol Venereol 2003 Apr; 130 (4): 439-42

Aminophylline: fatal anaphylaxis (serious) Victorov OP, Sharayeva M. Concomitant drug use and fatal ADR case report.Pharmacoepidemiol Drug Saf 2003 Oct; 12 Suppl. 2: 272

Aripiprazole: extrapyramidal disorder(serious)

Lindsey RL, Kaplan D, Koliatsos V, et al. Aripiprazole and extrapyramidal symptoms. J AmAcad Child Adolesc Psychiatry 2003 Nov; 42 (11): 1268-9

Aspirin overdose: fatal myocardial necrosisin a child (serious)

Peña-Alonso YR, Montoya-Cabrera MA, Bustos-Córdoba E, et al. Aspirin intoxication in achild associated with myocardial necrosis: is this a drug-related lesion? Pediatr Dev Pathol2003 Jul-Aug; 6 (4): 342-7

Basiliximab: pulmonary oedema (serious) Bamgbola FO, Del Rio M, Kaskel FJ, et al. Non-cardiogenic pulmonary edema duringbasiliximab induction in three adolescent renal transplant patients. Pediatr Transplant 2003Aug; 7 (4): 315-20

Bee venom: seizures in a child Virányi M, Elek S, Kiss I. Can bee-venom induce convulsion? Pharmacoepidemiol Drug Saf2003 Oct; 12 Suppl. 2: 273

Capecitabine: fatal pneumatosis coli in anelderly patient (serious)

Setlik R, Dooley D. Fatal pneumatosis coli after capecitabine chemotherapy for colonicmalignancy. South Med J 2003; 96 Suppl. 1: 30

Carvedilol/furosemide: diabetes mellitus Kobayakawa N, Sawaki D, Otani Y, et al. A case of severe diabetes mellitus occurred duringmanagement of heart failure with carvedilol and furosemide. Cardiovasc Drugs Ther 2003May; 17 (3): 295

Cefalexin: thrombotic thrombocytopenicpurpura (serious)

Baron BW, vanBesien K, Hoffman PC, et al. Thrombotic thrombocytopenic purpura aftercephalosporin administration: a possible relationship. Transfusion 2003 Sep; 43 (9): 1317-21

Cisapride: CNS disorders in an infant Torringa MLJ, van Roon EN, de Vries TW. CNS adverse effects of cisapride in children. AnnPharmacother 2003 Sep; 37 (9): 1344

Citalopram: cholestasis (serious) Milkiewicz P, Chilton AP, Hubscher SG, et al. Antidepressant induced cholestasis:hepatocellular redistribution of multidrug resistant protein (MRP2). Gut 2003 Feb; 52 (2): 300-3

Colchicine: acute hepatitis Gautam M, Islam T, Shaikh N, et al. Colchicine: an unusual cause of acute hepatitis. Am JGastroenterol 2003 Sep; 98 (9 Suppl.): 98

Cytarabine: pleural effusion (serious) Gähler A, Hitz F, Hess U, et al. Acute pericarditis and pleural effusion complicatingcytarabine chemotherapy. Onkologie 2003 Aug; 26 (4): 348-50

Dexchlorpheniramine: aseptic meningitis(serious)

LaFaurie M, Dixmier A, Molina JM. Aseptic meningitis associated with intravenousadministration of dexchlorpheniramine. Ann Med Interne (Paris) 2003 May; 154 (3); 179-80

Docetaxel: epistaxis (serious) Esmaeli B, Burnstine MA, Ahmadi MA, et al. Docetaxel-induced histologic changes in thelacrimal sac and the nasal mucosa. Ophthal Plast Reconstr Surg 2003 Jul; 19 (4): 305-8

Doxycycline: autoimmune hepatitis in achild? (serious)

Selimoglu MA, Ertekin V. Autoimmune hepatitis triggered by Brucella infection or doxycyclineor both. Int J Clin Pract 2003 Sep; 57 (7): 639-41

Enoxaparin sodium: immunethrombocytopenic purpura (serious)

Waheed F, Naseer N, Ahmed T, et al. Two patients with heparin-induced thrombocytopeniafollowed by idiopathic (Immune) thrombocytopenic purpura: case report. Am J Hematol 2003Aug; 73 (4): 290-3

Etanercept: thrombocytopenia in an elderlypatient

Stevenson DE, Wood R. Leukopenia and thrombocytopenia after administration ofetanercept in a patient with rheumatoid arthritis: case report and review of the literature.South Med J 2003 Oct; 96 Suppl. 1: 75

Etanercept: sarcoidosis and uveitis in a child(serious)

Hashkes PJ, Shajrawi I. Sarcoid-related uveitis occuring during etanercept therapy. Clin ExpRheumatol 2003 Sep-Oct; 21 (5): 645-6

Hepatitis B vaccine: Henoch-Schöenleinpurpura (serious)

Chave T, Neal C, Camp R. Henoch-Schöenlein purpura following hepatitis B vaccination. JDermatolog Treat 2003 Sep; 14 (3): 179-81

DRUG REACTIONS AND INTERACTIONS

The following table contains an overview of first published case reports of adverse drug reactions identified in theinternational literature in recent weeks by the drug safety alerting service Reactions Weekly.1

1 Reactions Weekly provides rapid alerts to news on drug safety. Summarising information selected from over 1700 biomedical publications, this newsletteris produced by Adis International Limited and is available in a variety of formats. Please contact your nearest Adis office for subscription details.

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1172-0360/04/002-0023/$31.00 © 2004 Adis Data Information BV. All rights reserved

Hydroxychloroquine: heart block due topacemaker failure in an elderly patient

Huang PH, Tuan TC, Lin YJ, et al. Implanted pacemaker failure caused by the antirheumaticdrug hydroxychloroquine. Lupus 2003; 12 (9): 725-7

Imiquimod: vulvar pemphigus Campagne G, Roca M, Martínez A. Successful treatment of a high-grade intraepithelialneoplasia with imiquimod, with vulvar pemphigus as a side effect. Eur J Obstet GynecolReprod Biol 2003 Aug; 109 (2): 224-7

Infliximab: angina pectoris Kayser Jr RG, Mounsey JP, Moss LJ. Microvascular angina in Crohn’s disease aftertreatment with infliximab. South Med J 2003 Oct; 96 Suppl. 1: 43

Infliximab: cutaneous tuberculosis (serious) Patel S, Kulkarni A, Agrawal R, et al. Cutaneous tuberculosis associated with infliximabtreatment. Am J Gastroenterol 2003 Sep; 98 (9 Suppl.): 185-6

Interferon-α: ageusia Aleixandre SI, Eguzkiza AC, Fernández FJF. Reversible ageusia and hyposmia induced byinterferon in a patient with chronic hepatitis C. Rev Esp Enferm Dig 2003 May; 95 (5): 364-5

Latanoprost: acute angle-closure glaucomain elderly patients (serious)

Yalvac IS, Tamcelik N, Duman S. Acute angle-closure glaucoma associated with latanoprost.Jpn J Ophthalmol 2003 Sep-Oct; 47 (5): 530-1

Methadone: torsade de pointes (serious) Walker PW, Klein D, Kasza L. High dose methadone and ventricular arrhythmias: a report ofthree cases. Pain 2003 Jun; 103 (3): 321-4

Moxifloxacin: hepatitis in an elderly patient(serious)

Chahine C, Cohen H, Mukherji R, et al. Moxifloxacin-induced hepatitis. Pharmacotherapy2003 Oct 10; 23 (10): 1328

Naphazoline: heart arrest followingaccidental intramucosal injection (serious)

Villeret I, Tellier AC, Erhmann S, et al. Cardiac arrest and secondary pulmonary oedemafollowing accidental intramucosal injection of naphazoline in an adult. Ann Fr Anesth Reanim2003 May; 22 (5): 477-80

Nitroglycerin: aggravation of preeclampticposterior reversible encephalopathysyndrome (serious)

Finsterer J, Schlager T, Kopsa W, et al. Nitroglycerin-aggravated pre-eclamptic posteriorreversible encephalopathy syndrome (PRES). Neurology 2003 Sep 9; 61 (5): 715-6

PEG-interferon-α-2b: vision loss (serious) Rubio JE, Charles S. Interferon-associated combined branch retinal artery and centralretinal vein obstruction. Retina 2003 Aug; 23 (4): 546-8

PEG-interferon-α-2b/ribavirin: nephroticsyndrome (serious)

Spinzi G, Grillo P, Terreni N, et al. Nephrotic syndrome during treatment with pegylatedinterferon alfa and ribavirin: a case report. Am J Gastroenterol 2003 Sep; 98 (9 Suppl.): 137

PEG-interferon-α-2b/ribavirin: lichen planus Bal JS, Wong H, Prajapati DN. Development of lichen planus during pegylated interferonalfa-2B and ribavirin therapy for hepatitis C. Am J Gastroenterol 2003 Sep; 98 (9 Suppl.): 205

PEG-interferon-α-2b/ribavirin: ischaemiccolitis (serious)

Raza Anees M, Qadri M, Anees F, et al. Ischemic colitis: a rare complication of hepatitis Ctherapy with peginterferon and ribavirin. Am J Gastroenterol 2003 Sep; 98 (9 Suppl.): 206

Phenol: pneumonitis Lattuneddu A, Farneti F, Lucci E, et al. A pulmonary allergic reaction after injectionsclerotherapy for hemorrhoids. Int J Colorectal Dis 2003 Sep; 18 (5): 459-60

Prednisone/tacrolimus: subcutaneousalveolar echinococcosis (serious)

Kolligs FT, Gerbes AL, Durr EM, et al. 52-year old patient with subcutaneous tumour underimmunosuppressive therapy - primary subcutaneous alveolar echinococcosis withhepatitis-C reinfection after liver transplantation. Internist 2003 Jun; 44 (6): 740-5

Pyrazinamide/rifampicin: acute autoimmunehepatitis and thyroiditis (serious)

Novak DJ, Gange CA, Clement S, et al. Pyrazinamide/rifampin induced acute autoimmunehepatitis and thyroiditis: an unusual reaction. Am J Gastroenterol 2003 Sep; 98 (9 Suppl.): 96-7

Tenofovir disoproxil fumarate:rhabdomyolysis

Callens S, De Roo A, Colebunders R. Fanconi-like syndrome and rhabdomyolysis in aperson with HIV infection on highly active antiretroviral treatment including tenofovir. J Infect2003 Oct; 47 (3): 262-3

Thyrotropin alfa: polymyalgia rheumatica Bagrel L, Le Berruyer PY, Molia A, et al. Thyrogen induced polymyalgia rheumatica.Pharmacoepidemiol Drug Saf 2003 Oct; 12 Suppl. 2: 206-7

Thyrotropin alfa: neurological disorders Hehn M, Degouy A, Pottier C, et al. Neurological adverse events after Thyrogenintramuscular injection. Pharmacoepidemiol Drug Saf 2003 Oct; 12 Suppl. 2: 230-1

Thyrotropin-alfa: respiratory failure (serious) Goffman T, Loffe V, Tuttle M, et al. Near-lethal respiratory failure after recombinant humanthyroid-stimulating hormone use in a patient with metastatic thyroid carcinoma. Thyroid 2003Aug; 13 (8): 827-30

Tolperisone: anaphylaxis (serious) Ribi C, Vermeulen C, Hauser C. Anaphylactic reactions to tolperisone (Mydocalm). SwissMed Wkly 2003 Jun 28; 133 (25-26): 369-71

Valproate semisodium: pseudotumourcerebri (serious)

Salah Uddin ABM. Drug-induced pseudotumor cerebri. Clin Neuropharmacol 2003 Sep-Oct;26 (5): 236-8

Valproic acid overdose: ECG changes Muñiz AE. Electrocardiographic changes with valproic acid overdose. South Med J 2003Oct; 96 Suppl. 1: 11-2

Zafirlukast: acute renal failure and nephroticsyndrome (serious)

Kumagai T, Hori Y, Kishida Y, et al. Acute renal failure and nephrotic syndrome associatedwith zafirlukast therapy. Nephrol Dial Transplant 2003 Oct; 18 (10): 2202-3

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

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Drugs & Therapy Perspectives 2004 Feb; Vol. 20, No. 2