Magazine article Drug Topics

Globulin Goblins

Magazine article Drug Topics

Globulin Goblins

Article excerpt

Shortfall in immune globulin supplies looms

Supplies of immune globulin products are shrinking nationwide, and no one knows why. The Food & Drug Administration is investigating the problem, while healthcare professionals try to prioritize patients and locate alternatives. There are shortages of both intravenously injected (IVIG) and intramuscularly injected (IMIG) immune globulin products, although the IVIG shortage is more acute-and more mysterious. Officials and industry believe the IMIG shortage, caused by production delays, is temporary, and they are concentrating instead on the IVIG shortfall.

"We still don't have any indication of the severity of the IVIG shortage," said Jason Bablek, director of regulatory affairs for the International Plasma Products Industry Association in Washington, D. C. Bablek believes a major reason could be the increasing use of IVIG. "Basically, it's just being used more than it can be produced at the moment." IVIG is indicated for a range of immunorelated diseases but has enjoyed off-label popularity for more than 50 other conditions, including chronic fatigue syndrome and several neurological disorders.

Other factors for the IVIG shortage may be production delays among the nation's six manufacturers, as well as recalls fueled by fears over the spread of Creuzfeldt-Jakob disease (CJD). In 1997, the FDA ordered more than a dozen recalls of IVIG products after learning of donors with CJD or at risk for developing it, even though "there is no scientific proof that CJD can be transmitted through blood or blood products," according to Bablek. Manufacturers willingly comply with the FDA's conservative policy "just in case."

Until the extent and causes of the shortage are known, it's anyone's guess when it will be over. But there may be a silver lining for one manufacturer. MedImmune Inc., of Gaithersburg, Md., said recent studies have shown its CytoGam (cytomegalovirus [CMV] immune globulin intravenous [human]) to be comparable to IVIG therapy for a number of conditions. CytoGam is indicated for attenuation of primary CMV disease associated with kidney transplantation. Medimmune's director of medical information, Robert J. Fuentes, Pharm.D., said that as the shortage becomes more severe, more practitioners are substituting CytoGam-despite its significantly higher cost. "Our sales almost quadrupled for December." He has been deluged with calls from hospital R.Ph.s and others asking about IVIG/CytoGam comparisons. At press time, Fuentes said that demand was continuing to rise and that all orders after Jan. …

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