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Findings from Istanbul University, Department of Internal Medicine in adverse drug reactions reported



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2008 JAN 29 -- Scientists discuss in 'Safety of high-dose intravenous immunoglobulin in systemic autoimmune diseases' new findings in adverse drug reactions. According to a study from Istanbul, Turkey, "It is reported that the usage of high-dose intravenous immunoglobulin (HD-IVIG) in systemic autoimmune diseases is associated with various adverse events in a wide range of severity. We aimed to investigate the frequency and profile of adverse events in a group of patients with diffuse connective tissue diseases and Wegener's granulomatosis (WG) who were administrated HD-IVIG for different indications."

"We recorded the data of 38 patients (25 females and 13 males) aged 38 ±15 (12-75) years who were followed up with the diagnosis of systemic autoimmune diseases between 1994 and 2006 according to a predefined protocol. Patients with active disease were treated with HD-IVIG and standard immunosuppressives concomitantly. We evaluated the occurrence of allergy, acute renal failure, thromboembolic events, neutropenia, hemolytic anemia, aseptic meningitis, and vasculitis during infusion therapy of HD-IVIG and in the following 3 weeks. We commenced a total of 130 infusions of HD-IVIG. Patients were administrated 1-12 (3.4 ±2.6) infusions of HD-IVIG as needed. Indications for HD-IVIG were unresponsiveness or partial response to standard treatment, severe infections along with disease activity, and severe thrombocytopenia in the preoperative period in 97, 23, and 5% of patients, respectively. Minor adverse events were seen in two patients during HD-IVIG infusions. One patient with WG developed rapidly progressive renal failure during severe disease flare between HD-IVIG infusions. Another patient with WG developed recurrence of deep-vein thrombosis during severe disease flare 3 months after HD-IVIG. Both events were attributed to severe disease activity. Adverse events like allergy, acute renal failure, thromboembolic events, hematological problems, aseptic meningitis, and vasculitis are reported in different frequencies (1-81%) in patients who were administered HD-IVIG for systemic autoimmune diseases," wrote F. Tufan and colleagues, Istanbul University, Department of Internal Medicine.

The researchers concluded: "HD-IVIG is considered a safe treatment in selected patients assuring adequate infusion precautions."

Tufan and colleagues published their study in Clinical Rheumatology (Safety of high-dose intravenous immunoglobulin in systemic autoimmune diseases. Clinical Rheumatology, 2007;26(11):1913-5).

For more information, contact F. Tufan, Istanbul Medical Faculty, Dept. of Internal Medicine, Istanbul University, Istanbul, Turkey.

Publisher contact information for the journal Clinical Rheumatology is: Springer, 233 Spring Street, New York, NY 10013, USA.

Keywords: Turkey, Istanbul, Adverse Drug Reactions, Acute Kidney Failure, Acute Renal Failure, Adverse Drug Effect, Adverse Drug Event, Adverse Drug Reaction, Allergies, Allergy Medicine, Aseptic Meningitis, Autoimmune Diseases, Autoimmune Disorder, Central Nervous System Disease, Connective Tissue Disease, Dermatology, Granulomatosis, Hematology, Hemolytic Anemia, Immunology, Internal Medicine, Intravenous Immunoglobulin, Kidney, Meningitis, Nephrology, Neutropenia, Renal Failure, Rheumatology, Therapy, Treatment, Vasculitis, Viral Research, Virology, Wegener Granulomatosis.

This article was prepared by World Disease Weekly editors from staff and other reports. Copyright 2008, World Disease Weekly via NewsRx.com.