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First report of renal impairment, supraventricular tachycardia and confusion, following intrathecal administration: case report A 53-year-old man developed renal impairment, supraventricular tachycardia and confusion after receiving dibotermin-alfa during fusion surgery for bilateral radiculopathy. Prior to surgery, intrathecal dibotermin-alfa [dosage not stated] was administered. The next day, he experienced supraventricular tachycardia (heart rate 150–160bpm) for 3–4 minutes, resolving spontaneously. He also had a fever of 38.6°C. Over the following year, he experienced severe back pain, and imaging studies revealed pseudarthrosis. He subsequently underwent surgery again. After 3 days, he developed a fever of 38.3°C. Five months later, he returned with back pain and signs of failed fusion. He underwent a third fusion operation, involving the use of sponges soaked in dibotermin-alfa [dosage not stated]. On postoperative day 7, his serum creatinine and blood urea nitrogen levels increased to 3.2 mg/dL and 53 mg/dL, respectively. Three days later, he developed supraventricular tachycardia (heart rate >160bpm) and hypoxia. His temperature reached 38.5°C. A Swan-Ganz catheterisation showed hyperdynamic cardiac function and low systemic vascular resistance, indicating sepsis. The man received antibacterials and heparin. The fevers continued intermittently for 3 weeks, with occasional confusion and altered mental status. Synovial fluid aspirated from his knee and elbow due to joint pain contained uric acid crystals. On postoperative day 31, he was initiated on prednisone. After 6 weeks of limited mobility, his level of activity gradually increased, and he was discharged to a rehabilitation centre 7 weeks after the third fusion operation. Author comment: "Although the present study does not prove that the patient’s postoperative complications were caused by [dibotermin-alfa] exposure, the protein appears to have provoked a systemic response that increased in magnitude after a second exposure." Moshel YA, et al. Acute renal insufficiency, supraventricular tachycardia, and confusion after recombinant human bone morphogenetic protein-2 implantation for lumbosacral spine fusion - case report. Journal of Neurosurgery - Spine 8: 801111843 589-593, No. 6, Jun 2008 - USA

» Editorial comment: A search of AdisBase, Medline, Embase and the WHO Adverse Drug Reactions database did not reveal any previous case reports of abnormal renal function, acute renal failure, supraventricular tachycardia or confusion, associated with dibotermin-alfa.

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Reactions 12 Jul 2008 No. 1210