Adverse reactions after high-dose intravenous immunoglobulin: incidence in 83 patients treated for idiopathic thrombocytopenic purpura (ITP) and review of the literature.

BACKGROUND: High dose intravenous immunoglobulin (h.d. Ig) is increasingly used in several hematological diseases. There are few data on the safety and no review of side effects after this treatment is available. We review here the literature on reported adverse reactions after h.d. Ig and report our own experience in the management of 83 patients with idiopathic thrombocytopenic purpura (ITP). PATIENTS AND METHODS: Computer assisted (Medline) and manual searches of the cumulative Index Medicus were undertaken to retrieve articles reporting side effects after infusion of h.d. Ig, published between 1981 and August 1993. Our own experience is based on clinical records of 83 patients, 56 females, 27 male, with a median age of 61 years (range 8-84), treated with h.d. Ig for acute or chronic ITP between 1985 and June 1993. RESULTS AND DISCUSSION: Major adverse reactions included aseptic meningitis (14 cases), hemolytic anemia (8 cases) and renal dysfunction (12 cases). The most frequently reported mild side effect was headache. We have had 2 cases of severe skin reactions, 1 case of acute renal failure, 3 cases of severe headache and 1 case of chills and fever. For other 3 cases, an anaphylactic/oid reaction, caused by a too rapid infusion rate, occurred. Thus, 10/83 (12%) patients, 7 female and 3 male, developed side effects, but they were unpredictable and severe in only 3 cases (4%). Side effects developed only in 21/480 (4%) infusions.