Baxter's Gammagard linked to hepatitis

30 July 1995

- The US Food and Drug Administration says that as many as 1,000 cases of hepatitis C could be linked to use of Baxter's immunoglobulin product Gammagard. The company, which faces about 50 federal lawsuits for negligence in Los Angeles and several more in state courts, received US approval to market Gammagard in 1986 without a requirement to include a virus-killing step in the drug's manufacturing process. Baxter now sells a virally-inactivated version of the drug called Gammagard S/D, and says it did not impose the virus-killing step earlier because its experience indicated that other immunoglobulin products already on the market (untreated) did not transmit the virus.

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