Baxter, Red Cross Warn Against Rapid Infusion of IGIV
The letters, which were described in an April 22 alert from MedWatch, the Food and Drug Administration's (FDA's) safety and adverse-event reporting program, discourage the rapid infusion of IGIV in patients at risk for thrombotic events. FDA noted that the labeling for IGIV productsBaxter's Gammagard S/D and American Red Cross' Polygam S/Dhas been revised to include precautionary statements about administering IGIV to patients with a history of cardiovascular disease or thrombosis.
According to the manufacturers' letters, patients who are at risk for thrombosis should be given IGIV at an infusion concentration of 5 percent or less. For such patients, the starting infusion rate should be no greater than 0.5 ml/kg of body weight per hour. The manufacturers stated that the infusion rate can be slowly increased to 4.0 ml/kg of body weight per hour if the product is well tolerated.
In their "Dear Healthcare Provider" letters, Baxter and the Red Cross described a study published last year in which IGIV was administered at up to 800 ml/hour in patients with neuromuscular disorders. Although the study had described the infusion regimen as safe and convenient, Baxter and the Red Cross calculated that 11 of 50 patients involved in the study had had a major thrombotic event.
According to the manufacturers, adverse events that were "almost certainly directly related to the rapid infusion protocol" included chest pain, myocardial infarction, congestive heart failure, severe headache, and pulmonary embolism.
Baxter and the Red Cross urged pharmacists and other health care providers to read and follow the package insert before administering IGIV to patients.