FDA strengthens HBV warning of two cancer drugs

As reported by Reuters (9/26, Clarke), the U.S. Food and Drug Administration has announced that GlaxoSmithKline Plc’s chronic lymphocytic leukemia (CLL) drug, Arzerra, and Roche Holding AG and Biogen Idec Inc’s drug, Rituxan, will now contain black box warnings on “the risk that they may reactivate the hepatitis B virus in patients previously infected with the disease.”

Hepatitis B is a serious liver infection that can become chronic and lead to liver failure, liver cancer or cirrhosis, a condition that causes permanent scarring of the liver.

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