Labeling Change for Rituximab (Rituxan)
In seven of the eight fatalities, severe symptoms occurred during the first Rituxan? (rituximab) infusion. The cause of death was not reported or remains unknown for two of the eight cases. In most cases, death was preceded by severe bronchospasm, dyspnea, hypotension, and/or angioedema. Severe respiratory events, including hypoxia, pulmonary infiltrates, and adult respiratory distress syndrome, contributed to six of the eight reported deaths. In some cases symptoms worsened over time, while in others initial improvement was followed by clinical deterioration. Therefore, patients experiencing any of the symptoms mentioned above or in the labeling (see ADVERSE REACTIONS section of the package insert) should be monitored closely until complete resolution of their symptoms occurs.