BAXTER WITHDRAWS GAMMAGARD

14 March 1994

Baxter Healthcare is voluntarily withdrawing worldwide stocks of the immunoglobulin product Gammagard, due to the product's "possible contamination with hepatitis C virus."

The company initiated the withdrawal after receiving 14 physician reports of patients with either laboratory evidence or laboratory and clinical evidence of hepatitis following Gammagard treatment. Eight of the reports came from Spain, four from Sweden and two from the USA.

Of the patients mentioned in the report, three from Spain and two from Sweden show HCV laboratory markers. The other patients either fail to show HCV laboratory markers, or they show markers but the significance is "confounded" by other abnormal laboratory changes, states the report. Bill Mutert, a spokesman for Baxter Hyland, said that the first five patients are the only patients so far which have been shown to have contracted the virus, although he added that it is not definite that the virus was passed via Gammagard, but conceded that it did seem the likely mode of transmission.

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