Immune Globulin Shortage Threat To Nation During Cold, Flu Season
A severe nationwide shortage of immune globulin has suddenly developed at the peak of the cold and flu season, endangering tens of thousands of people who need the medicine because of deficient immune systems and other conditions.
Increased demand, production problems and product recalls have made it extremely difficult to obtain the blood-based medicine.
“In the last couple weeks, it has gone from short supply to not available at all,” said Jason Bablak, spokesman for International Plasma Products Industry Association.
Without monthly intravenous doses, tens of thousands of patients, many of them children born without working immune systems, risk debilitating illnesses and death from common ailments.
“I’ve lost two boys with hemophilia to AIDS already, and I’m terrified of losing Teddy,” said Elaine DePrince, a Cherry Hill mother whose three adopted sons with hemophilia contracted AIDS from tainted blood-clotting products.
Teddy, 17, needs a monthly dose because his body cannot make antibodies. DePrince said Thursday that the home care company providing the medication is unsure when it can get any because of the nationwide shortage.
The Food and Drug Administration, which inspects every lot of the medicine before it is sold, is “working closely with manufacturers to expedite distribution of all available product without compromising safety,” FDA blood chief Dr. Jay Epstein said Thursday.
No one knows when the shortage will end, although Alpha Therapeutic of Los Angeles, Bayer Pharmaceutical of West Haven, onn., and Baxter Healthcare of Deerfield, Ill., are awaiting approval to expand production.
The other manufacturers are Novartis of East Hanover and Centeon of King of Prussia, Pa.
Immune globulin is made by separating antibodies from blood plasma.
Besides pediatric AIDS, the FDA has approved immune globulin for patients getting bone marrow transplants or with primary immune deficiency, which comprises dozens of inherited immune disorders. About 25,000 PID patients need a dose every three or four weeks.