Intravenous immune globulin and thromboembolic adverse events in patients with hematologic malignancy

Abstract

• Acute myocardial infarction and ischemic stroke risk was 3 times higher during days 0 to 1 following IVIg treatment in patients with secondary hypogammaglobulinemia.• In patients treated with IVIg for 1 year, the estimated increase in the absolute risk of a severe thromboembolic event was ;1%.

Association of immune globulin intravenous and thromboembolic adverse events

“…We thank Ovanesov et al for their letter 1 and discussion of research concerning IVIg-associated thromboembolic adverse events (TEEs). [2][3][4][5][6] We agree that our study 7 does not rule out a causal relationship between IVIg and increased TEE risk. As they note, TEEs are rare events, limiting our power to rule out a clinically meaningful increased risk of TEEs in the trial populations included in our meta-analysis.…”

“…In contrast, an earlier study by Amman et al with a larger number of patients (8035 non-users and 2724 users of IG) involving chronic lymphocytic and multiple myeloma patients, showed a threefold higher rate of arterial TEEs in the first day of IG infusion. 6 Both of FDA's epidemiological studies 4,5 were based on substantially greater numbers of exposed persons Sentinel BloodSCAN study. The FDA conclusion from the available data is that the risk of thrombosis from IG products is small but not zero.…”

A reply to Ovanesov et al.

“…We thank Ovanesov et al for their letter 1 and discussion of research concerning IVIg-associated thromboembolic adverse events (TEEs). [2][3][4][5][6] We agree that our study 7 does not rule out a causal relationship between IVIg and increased TEE risk. As they note, TEEs are rare events, limiting our power to rule out a clinically meaningful increased risk of TEEs in the trial populations included in our meta-analysis.…”

“…However, data from observational studies of IVIg-associated TEEs should also be considered, particularly for assessing risk in patients of advanced age or with other major TEE risk factors. [4][5][6]8,9 Eric M. Ammann, Elizabeth A. Chrischilles…”

Intravenous immune globulin and thromboembolic adverse events: A systematic review and meta‐analysis of RCTs

“…Intravenous immune globulin (IVIg) is used to treat a variety of conditions, including antibody deficiencies and several autoimmune and/or inflammatory disorders (e.g., chronic inflammatory demyelinating polyneuropathy) . Although IVIg products have had a generally good safety record, laboratory assessments, case reports, and prior observational studies have suggested a potential causal link between IVIg products and an increased risk of serious thromboembolic adverse events (TEEs) . In 2003, the U.S. Food and Drug Administration (FDA) began requiring manufacturers to include a warning about TEEs in IVIg product packaging ; this advisory was elevated to a more prominent boxed warning in 2013 .…”