FDA modifies black-box label on Lantheus Definity contrast agent
The FDA has revised its boxed warning, warnings and contraindications sections of the prescribing information for Lantheus Medical Imaging’s Definity contrast agent (Perflutren Lipid Microsphere).
The revisions supercede the FDA-mandated label changes made in October 2007, according to Lantheus.
The company said its label’s contraindications have been revised to the following: “Do not administer Definity to patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts, hypersensitivity to perflutren. Do not administer Definity by intra-arterial injection.”
All other contraindications have been removed from the contraindications section of the label and the boxed warning and warnings sections have been revised to reflect monitoring in only patients with pulmonary hypertension or unstable cardiopulmonary conditions as compared to the previous label which included language regarding monitoring in all patients, according to Lantheus.
In October 2007, the FDA added a black box warning to Definity, due to reports of “deaths and serious cardiopulmonary reactions,” according to the agency. However, presenters at ACC08 said that the FDA should reconsider a strong warning it issued on ultrasound contrast agents based on their study results.
Based on an extensive and thorough review of recent safety information provided to the FDA by Lantheus and members of the echocardiography community, the prescribing information revisions modify Definity’s benefit and risk assessment, according to the North Billerica, Mass.-based company.
The revisions supercede the FDA-mandated label changes made in October 2007, according to Lantheus.
The company said its label’s contraindications have been revised to the following: “Do not administer Definity to patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts, hypersensitivity to perflutren. Do not administer Definity by intra-arterial injection.”
All other contraindications have been removed from the contraindications section of the label and the boxed warning and warnings sections have been revised to reflect monitoring in only patients with pulmonary hypertension or unstable cardiopulmonary conditions as compared to the previous label which included language regarding monitoring in all patients, according to Lantheus.
In October 2007, the FDA added a black box warning to Definity, due to reports of “deaths and serious cardiopulmonary reactions,” according to the agency. However, presenters at ACC08 said that the FDA should reconsider a strong warning it issued on ultrasound contrast agents based on their study results.
Based on an extensive and thorough review of recent safety information provided to the FDA by Lantheus and members of the echocardiography community, the prescribing information revisions modify Definity’s benefit and risk assessment, according to the North Billerica, Mass.-based company.