US FDA warns of hepatitis B reactivation risk with Arzerra and Rituxan
The US Food and Drug Administration has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab), from UK pharma giant GlaxoSmithKline (LSE: GSK), and Rituxan (rituximab) from Swiss drug major Roche (ROG: SIX) and Biogen Idec.
The FDA wants to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The revised labels will also include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk. Both Arzerra and Rituxan are used to treat certain cancers of the blood and lymph system. Rituxan is also approved to treat other medical conditions, including rheumatoid arthritis. Both drugs suppress the body's immune system.
Danger of reactivation
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