Pharmacy Division Ramathibodi Hospital


First Reports of Adverse Drug Reactions (ADRs) in 2002

The following table contains an overview of first published case reports of adverse drug reactions identified in the international literature in the year 2002.

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
Ceftriaxone/cefepime/ceftazidime: status epilepticus in patients with renal failure Martinez-Rodreguez JE, Barriga FJ, Santamaria J, et al. Nonconvulsive status epilepticus associated with cephalosporins in patients with renal failure. Am J Med 2001 Aug; 111: 115-9
Celecoxib: Sweet's syndrome Fye KH, Crowley E, Berger TG, et al. Celecoxib-induced Sweet's syndrome. J Am Acad Dermatol 2001 Aug; 45: 300-2
Chlorhexidine: allergic contact balanitis Barrazza V. Connubial allergic contact balanitis due to chlorhexidine. Contact Dermat 2001 Jul; 45: 42
Cyclosporin/prednisone: fatal angiosarcoma (serious) Schulze R, Schulze M, SalomonDani A, et al: Metastatic angiosarcoma of the right atrium during cyclosporin and prednisone immunosuppression after kidney transplantation. Internist 2001 Jan; 42: 119-23
Diltiazem: postoperative heamorrhage (serious) Yesudian PD, Velangi SS, Velangi MR, et al. Postopeartive bleeding in a patient on diltiazem. Br J Dermatol 2001 Jul; 145 Suppl. 59: 87
Eptifibatide/alteplase: haemorrhage in an elderly patient Singh S, Methot M, LaHaye S, et al. Complications associated with glycoprotein IIB/IIIA antagonists after thrombolysis. Can J Hosp Pharm 2001; 54: 152
Isotretinoin: onycholysis, cheilitis, nail fragility Onder M, Oztas MO, Oztas P. Isotretinoin-induced nail fragility and onycholysis. J Dermatol Treat 2001 Jun; 12: 115-6
Meropenem: allergic contact dermatitis Yesudian PD, King CM. Occupational allergic contact dermatitis from meropenem. Contact Dermat 2001 Jul; 45: 53
Paclitaxel: ischaemic colitis Daniele B, Rossi GB, Losito S, et al. Ischemic colitis associated with paclitaxel. J Clin Gastroenterol 2001 Aug: 33: 159-60
Rituximab: fatal reactivation of cytomegalovirus infection (serious) Suzan F, Ammor M, Ribrag V. Fatal reactivation of cytomegalovirus infection after use of rituximab for a post-transplantation lymphoproliferative disorder. NEJM 2001 Sep; 345: 1000
Sildenafil: heamorrhoidal haemorrhage Sheikh RA, Yasmeen S, Prindiville TP. Hemorrhoidal bleeding associated with sildenafil. Am J Gastroenterol 2001 Aug; 96: 2518-19
Sirolimus: femoral head necrosis (serious) Bhandari S, Eris J. Premature osteonecrosis and sirolimus treatment in renal transplantation. BMJ 2001 Sep; 323; 665
Trastuzumab: heart failure (serious) Strasser F, Betticher DC, Suter TM. Trastuzumab and breast cancer. NEJM 2001 Sep; 345: 996

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