Product Liability: FDA approves new boxed warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab)

Cases of hepatitis B reactivation leading to serious personal injury and death after cancer patients have been prescribed Arzerra (ofatumumab) and Rituxan (rituximab) are still occurring even though the risk of HBV reactivation is already described in the Warnings and Precautions section of the labels for both drugs. For this reason the FDA has recently approved changes to the prescribing information of these two drugs.The revised labels also will include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk.
Go to the FDA website to learn more and listen to a podcast on this subject.