Increased “Off-Label” Use of Immune Globulin Causing Shortages

Intravenous immune globulin (IVIG) is used to treat a broad range of life-threatening conditions that compromise the body’s immune system. Along with its long and costly manufacturing process, increased demand for such widespread use has contributed to nationwide shortages.

The treatment currently is FDA-approved for primary immunodeficiencies, Kawasaki disease, preventative care after bone marrow transplants, and chronic inflammatory demyelinating polyneuropathy. However, its off-label use – situations where it is prescribed for purposes not approved by the FDA – extends to secondary immunodeficiencies (such as those related to HIV, cancer, or cancer treatment) and recurrent infections. It’s even used to treat conditions “where it is ineffectual and may actually increase the risks to patients,” according to research published in the Journal of Allergy and Clinical Immunology.

“IVIG can be a useful treatment for evidence-based purposes, but it’s also often used as a last-chance, nothing-is-working Hail Mary kind of approach for myriad conditions even when there is not clear evidence that it helps the patient,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School.

Dr. Avorn mentioned that some of these uses may be driven by financial motivation. “Anytime an extremely costly infusion medicine is used in any setting, it’s worth looking at who benefits economically from its use, especially for conditions in which data on effectiveness is limited or absent,” he said.

Because the manufacturing process includes collecting plasma from healthy donors, processing, packaging, and shipping, immune globulin can take up to a year to produce.

Some hospitals handle shortages by prioritizing patients who do not have alternative options and whose lives would be threatened without the treatment, pushing patients who might be able to safely forgo the medication toward the bottom of the list.

Source: The Washington Post, September 20, 2019.