News | May 12, 2008

FDA Revises Label for DEFINITY Agent

May 13, 2008 – The FDA approved changes to the U.S. product label for DEFINITY Vial For (Perflutren Lipid Microsphere) Injectable Suspension to reflect monitoring in only patients with pulmonary hypertension or unstable cardiopulmonary conditions.

The DEFINITY label changes the FDA just approved supercede the FDA-mandated label changes that Lantheus announced in October 2007 and include revisions to the boxed warning, warnings and contraindications sections of the prescribing information. Similar label updates have been approved by the FDA for all perflutren-containing microsphere contrast agents.

The 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. The boxed warning and warninigs 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.

For full prescribing information: www.lantheus.com

Related Content

Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

News | Contrast Media | September 12, 2018
In February 2018, a workshop was held at the National Institutes of Health (NIH) in Bethesda, Maryland, to explore co
Ligand Establishes Program to Develop Captisol-Enabled, Next-Generation Diagnostic Imaging Contrast Agents
News | Contrast Media | January 19, 2018
Ligand Pharmaceuticals Inc. announced initiation of a program to develop contrast agents with reduced renal toxicity....
FDA Holds MIDAC Meeting on Gadolinium-Based Contrast Agents. Image by Marilyn Fornell
News | Contrast Media | September 07, 2017
The U.S. Food and Drug Administration (FDA) announced it would hold a meeting of the Medical Imaging Drugs Advisory...
European Medicines Agency Issues Update on Gadolinium Contrast Agents
News | Contrast Media | August 29, 2017
August 29, 2017 — The European Medicines Agency (EMA) issued a final opinion that recommended restricting the use of
Guerbet Announces Plans to Streamline Contrast Media Portfolio, gadolinium MRI contrast
News | Contrast Media | July 18, 2017
Guerbet recently announced that it will phase out sales throughout the world of two products: Hexabrix (meglumine and...
ACR Offers Revised Contrast Media in Imaging Manual
News | Contrast Media | July 17, 2017
The American College of Radiology (ACR) recently revised its authoritative guide for the safe and effective use of...
Bayer Arterion contrast Injector used to administer medical imaging contrast for CT scans.

Bayer Healthcare's Arterion contrast injector system.

Feature | Contrast Media | June 19, 2017 | Dave Fornell
Here are several updates in medical imaging...
PRAC, European Medicines Agency, gadolinium-based contrast agents, safety recommendations, brain MRI
News | Contrast Media | March 13, 2017
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recently released new...
Lantheus Medical Imaging, Definity, FDA approval, label update, echocardiography, cardiac shunt contraindication
Technology | Contrast Media | February 02, 2017
Lantheus Medical Imaging Inc. announced U.S. Food and Drug Administration (FDA) approval of a label update for Definity...
CT, computed tomography, IV contrast media, acute kidney injury risk, Annals of Emergency Medicine study

A new study in Annals of Emergency Medicine finds no association between intravenous contrast media used in computed tomography (CT) and kidney damage. Roughly 80 million doses of IV contrast media are given every year. Credit: American College of Emergency Physicians

News | Contrast Media | January 30, 2017
Intravenous contrast media (typically iohexol or iodixanol) used in computed tomography (CT) does not appear to be...
Overlay Init