Adverse events associated with intravenous immunoglobulin therapy.
In addition to its U.S. Food and Drug Administration (FDA) approved conditions, immune globulin intravenous (IGIV) is now being used to treat a vast array of autoimmune disorders. Some of the reasons for this overall increase in the use of IGIV include its effectiveness and safety. Despite many years of safe use, side effects and adverse reactions still occur. Common and mild side effects associated with IGIV include: headache, malaise, nausea, low-grade fever, urticaria, arthralgias, and myalgia. These symptoms typically resolve within a few days after their onset. Although rare, the serious and potentially fatal side effects include: anaphylactic reactions, aseptic meningitis, acute renal failure, stroke, myocardial infarction, and other thrombotic complications. Many of these side effects have occurred in patients who have significant, underlying risk factors for the development of the event. Thus, it is vitally important that a thorough and comprehensive medical evaluation be performed on every patient who is being evaluated for potential IGIV therapy. This evaluation can, to some extent, significantly minimize the risk of these side effects. Careful, constant, and close monitoring by trained personnel during the infusion can also result in early detection of such events. Physicians should thoroughly discuss the risks and benefits of IGIV with patients who are being considered for this therapy.