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Definity and Optison

Definity and Optison Side Effects Have Been Linked To Severe Cardiac Reactions

Definity and Optison | Lawsuits, Lawyers | Side Effects: Cardiopulmonary, Severe Cardiac Reactions, Ultrasound Contrast

In October 2007, the makers of Definity and Optison, contrast agents used in ultrasounds of the heart, agreed to include a new black box warning on their package inserts after the Food and Drug Administration (FDA) received hundreds of reports of serious cardiac reactions and deaths associated with the administration of these drugs.

Definity, marketed by Bristol Myers Squibb, and Optison, distributed by General Electric, are known as micro-bubble contrast agents. Definity and Optison contrast agents are used in ultrasounds of the heart to enhance images during a procedure called echocardiography. During an echocardiography, the contrast agents are injected into a patient's veins. The drugs consist of microscopic gas-filled spheres that sharpen the resulting ultrasound picture. The use of Definity or Optison contrast agents allow doctors to better diagnose heart defects and malfunctions.

According to the FDA, there have been more than 200 reports of serious cardiac reactions involving the use of Definity and Optison. In October 2007, the FDA said that it knew of at least 11 deaths associated with the administration of either Definity or Optison. Four of those fatalities occurred either during infusion or within 30 minutes following the administration of the contrast agent. The FDA said that most of the serious but non-fatal reactions also occurred in the same time frame.

Definity and Optison Black Box Warning

As a result of these reports, the FDA requested that the labeling on Definity and Optison be modified to include a black box warning about the cardiac problems associated with these agents. A black box warning is the FDA's strictest type of warning. The Definity and Optison package inserts now warn that patients could experience cardiac events during, and within 30 minutes of infusion. The FDA also warned that these contrast agents should not be administered to patients with: right-to-left, bi-directional, or transient right-to-left cardiac shunts; clinically unstable or recent worsening congestive heart failure; acute myocardial infarction; serious ventricular arrhythmias or at high risk for arrhythmias due to QT prolongation; respiratory failure; and severe emphysema, pulmonary emboli or other conditions that compromise pulmonary arterial vasculature.

The new black box also warned physicians to monitor all patients receiving micro-bubble contrast agents for serious cardiopulmonary reactions during the infusion and for 30 minutes following completion of administration. Healthcare providers were also advised to keep resuscitation equipment be on hand for half an hour after injecting the drug.

Legal Help For Victims Affected By Definity and Optison

If you or a loved one has been injured by Definity or Optison administered during an ultrasound, you may have valuable legal rights. Please fill out the form at the right for a free case review by a qualified attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).



 

Definity and OptisonRSS Feed

FDA Updates Definity Optison Warning

Jul 17, 2008 | Parker Waichman LLP
Healthcare providers were notified today about labeling changes for Definity and Optison, micro-bubble contrast agents used in sonograms of the heart.   The revised Boxed Warning and Warnings continue to highlight the risk of serious cardiopulmonary reactions during or within 30 minutes following the administration of Definity and Optison.  Definity, marketed by Lantheus Medical Imaging, and Optison, distributed by GE Healthcare, are used during echocardiograms, ultrasound...

Heart Imaging Agents Like Definity and Optison Need More Safety Studies, FDA Panel Says

Jun 25, 2008 | Parker Waichman LLP
Heart imaging contrast agents need to be subjected to more studies in order to insure their safety, a Food & Drug Administration (FDA) advisory panel said yesterday.  The contrast agents, sold under the brand names Definity and Optison, have been linked to more than 200 serious cardiac reactions and 11 deaths.  Definity, marketed by Lantheus Medical Imaging, and Optison, distributed by GE Healthcare, are used during echocardiograms, ultrasound imaging procedures that take a...

Definity and Optison Side Effects Still Concern FDA

Jun 23, 2008 | Parker Waichman LLP
Definity and Optison - micro-bubble contrast agents used in sonograms of the heart - are still endangering patients.   According to documents released Friday by the Food & Drug Administration (FDA), four more deaths have been linked to Definity since last fall, and the agency says it continues to be concerned over the safety of these agents.   These new revelations call into question the FDA's decision just last month to scale back warnings for Definity and Optison after...

Definity, Optison Black Box Warning Revised

May 14, 2008 | Parker Waichman LLP
The Food & Drug Administration (FDA) is watering down its warning about the possible risks of Definity and Optison, micro-bubble contrast agents used during ultrasounds of the heart to enhance images during a procedure called echocardiography.  Though the labels of the contrast agents will continue to bear a black box warning about the risk of serious, and sometimes fatal cardiopulmonary reactions, the FDA has dropped a ban on giving the agents to acutely ill patients, such as those...

Doctor Disputes FDA Black Box Warning on Ultrasound Contrast Agents

Apr 3, 2008 | Parker Waichman LLP
A controversy has erupted over the safety of ultrasound contrast agents used to diagnose heart defects and malfunctions.  Last year, the Food & Drug Administration (FDA) required the makers of ultrasound contrast agents - also known as micro-bubble contrast agents -  to include a black box warning on the products' labels about their association with serious cardiac injuries and deaths.  But one scientist who has researched the ultrasound contrast agents says they are safe,...

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