A severe shortage of immune globulin — a popular medicine used to treat epilepsy, cancer, and immune disorders — is forcing doctors nationwide to cancel patients’ lifesaving infusions as hospitals and treatment centers resort to rationing and dose-cutting.
Immune globulin helps protect patients from infections, and it is used to treat many medical conditions including seizures, leukemia, autoimmune diseases, organ transplants, acute muscle illnesses, and nerve disorders.
As off-label use spreads for lifesaving niche drugs, supplies grow scarce.
‘‘It is miraculous,’’ said John Boyle, president of the Immune Deficiency Foundation, a national nonprofit group representing patients with immune disorders, many of whom receive immune globulin. ‘‘It is the one thing, if you have an antibody deficiency, that gives you gas in the tank. It is necessary to live.’’
Made from human blood donations, immune globulin contains infection-fighting antibodies derived from blood plasma, and it is typically administered to patients intravenously in a hospital or an infusion center. The medicine is highly effective and has become popular in recent years among doctors who routinely prescribe it for off-label conditions.
Jerry Siegel, a clinical associate professor at Ohio State University College of Pharmacy, said doctors are using the treatment, known as IG therapy, as a medicine for ailments such as strep infections that have crossed the blood-brain barrier, infertility, and even toe fungus.
‘‘We don’t always know why it works, but it works,’’ Siegel said. ‘‘When it was taking off in the ‘80s, we would see patients come into the hospital on a gurney so flaccid they were unable to walk. The next day, after their IG therapy, they were able to get up and walk out the door. When you see some really profound results like that, it is really convincing to prescribers.’’
Shortages of immune globulin have become more frequent in the past few years, spurred by demand for the medicine. Nevertheless, manufacturers say the current shortage is among the worst they have experienced since the treatment has been on the market.
In a statement in August, the Food and Drug Administration said that ‘‘despite increased supply of immune globulin products in recent years, the demand for IG products has also increased over the same time and there is an ongoing shortage.’’
While the agency does not have the authority to force an increase in production, FDA officials said they are trying to help mitigate the shortage by working with drug companies to boost supply.
Even so, the shortage is depriving patients of crucial treatment, and some have resorted to desperate measures. In Orlando, Laurel Smith gave the hospital bottles of immune globulin so that they could continue treating her son, Lowry, 7, who suffers from a rare form of autoimmune encephalitis, called GAD-65, which means his immune system attacks his brain.
Lowry is treated with aggressive medicines that dampen his body’s immune response and leave him with no natural defenses against invading germs that can lead to illnesses and infections. As a result, Lowry gets intravenous immune globulin (IVIG) treatments every month. Without the treatments, exposure to the outside world could send him into a coma.
‘‘Lowry needs triple immune suppression to beat his disease, but he has become a bubble boy where a single infection could kill him without IVIG to give protection from day-to-day germs,’’ his mom said.
In 2017, just after Lowry was diagnosed with limbic encephalitis, his doctor ordered home health IVIG infusions. But doctors soon decided to give the infusions in a hospital as opposed to in the home along with other treatments, leaving his mother with two bottles of the immune globulin. Knowing its value, she held on to it for over two years, assuring it was always kept properly in case of an emergency. To everyone’s surprise, two years later, that emergency came when they were told that there were no more immune globulin supplies, the hospital could not obtain it, and Lowry’s infusion was canceled.
Michael Ganio, director of pharmacy practice and quality at the American Society of Health-System Pharmacists, a trade group, said that doctors are responding to the shortage by reducing doses and lengthening the time between treatments. He pointed out that, in the past few weeks, many medical offices have been calling patients to tell them that their infusion appointments were canceled. ‘‘People are taking a hard look at who is receiving the medicine, and really, is it the right treatment,’’ Ganio said.