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Reuters Health Information (2013-09-25): U.S. FDA strengthens hepatitis B warning on two cancer drugs

Regulatory

U.S. FDA strengthens hepatitis B warning on two cancer drugs

Last Updated: 2013-09-25 17:00:08 -0400 (Reuters Health)

WASHINGTON (Reuters) - U.S. health regulators have strengthened the warnings on two blood cancer drugs to reflect the risk that they may reactivate the hepatitis B virus in patients previously infected with the disease.

The warnings affect ofatumumab (Arzerra, GlaxoSmithKline), which is approved to treat chronic lymphocytic leukemia (CLL), and rituximab (Rituxan, Roche/Biogen), approved to treat a variety of conditions including CLL, non-Hodgkin's Lymphoma and rheumatoid arthritis.

The U.S. Food and Drug Administration said the risk is already described in the warnings and precautions section of the label for both drugs but that cases of reactivation continue to occur and some patients have died. Now the information will be placed in a black box, indicating the most serious type of risk.

Both drugs work by suppressing the immune system.

The FDA said it recommends that physicians screen all patients for hepatitis B infection before starting treatment with the drugs, and monitor patients with evidence of prior hepatitis B infection for signs that the virus has been reactivated, including for several months after therapy has stopped.

 
 
 
 
                 
 
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