Lantheus Medical Imaging announced it has made changes to the U.S. product label for its Definity ultrasound contrast agent.
After a review of Lantheus' 2010 application for proposed label changes that was submitted to the U.S. Food and Drug Administration (FDA), the following revisions have been made to Definity's prescribing information label:
- Removal of the following statement from the boxed warning section: "In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after Definity administration."
- Addition of the following statement to the boxed warning section: "Most serious reactions occur within 30 minutes of administration."
- Removal of the following statement from the product indications and usage section of the label: "The safety and efficacy of Definity with exercise stress or pharmacologic stress testing have not been established."
- Addition of the further qualifier in the following statement in the warning section: "Serious cardiopulmonary reactions, including fatalities, have occurred 'uncommonly' during or following perflutren-containing microsphere administration."
- Inclusion of summary data from the postapproval Contrast Echocardiography Registry for Safety Surveillance (CaRES) in the postmarketing experience section and from the postapproval pulmonary hypertension study in the clinical trials experience section.
