LAWSUITS NEWS & LEGAL INFORMATION
Definity and Optison
The FDA has received reports of deaths and serious cardiopulmonary reactions following the administration of ultrasound micro-bubble contrast agents used in echocardiography. Four of the 11 reported deaths were caused by cardiac arrest occurring either during infusion or within 30 minutes following the administration of the contrast agent; most of the serious but non-fatal reactions also occurred in this time frame.
As a result, the manufacturers of Definity and Optison have agreed to revise the labeling for these products in order to optimize their safe use. Revised labeling includes changes to the following sections: Boxed Warnings, Containdications, Warnings and a statement in the Indications section cautioning that the safety and efficacy of the use of Definity with exercise or pharmacological stress testing have not been established.
Together these labeling changes emphasize the risk for serious cardiopulmonary reactions, and that the use of these products is contraindicated in patients with unstable cardiopulmonary status, including patients with unstable angina, acute myocardial infarction, respiratory failure, or recent worsening congestive heart failure.
US regulators have alerted doctors about reports of deaths and serious reactions following the use of certain imaging agents to help diagnose heart problems. The contrast agents, Bristol-Myers Squibb Co's Definity and General Electric Co's Optison, are injected into some patients' veins before doctors view the heart via an ultrasound procedure known as echocardiography.
The FDA has been investigating reports of deaths and serious cardiopulmonary reactions after people were injected with either of the products.
Definity had 2006 sales of about $65 million. Optison was recalled by GE Healthcare in November 2005 because of manufacturing problems. The company hoped to relaunch the product in 2007. The products are made from gases enclosed in tiny capsules of protein or fatty material. They can help doctors visualize the borders of the heart more clearly and identify abnormalities.
Published on Oct-18-07
As a result, the manufacturers of Definity and Optison have agreed to revise the labeling for these products in order to optimize their safe use. Revised labeling includes changes to the following sections: Boxed Warnings, Containdications, Warnings and a statement in the Indications section cautioning that the safety and efficacy of the use of Definity with exercise or pharmacological stress testing have not been established.
Together these labeling changes emphasize the risk for serious cardiopulmonary reactions, and that the use of these products is contraindicated in patients with unstable cardiopulmonary status, including patients with unstable angina, acute myocardial infarction, respiratory failure, or recent worsening congestive heart failure.
US regulators have alerted doctors about reports of deaths and serious reactions following the use of certain imaging agents to help diagnose heart problems. The contrast agents, Bristol-Myers Squibb Co's Definity and General Electric Co's Optison, are injected into some patients' veins before doctors view the heart via an ultrasound procedure known as echocardiography.
The FDA has been investigating reports of deaths and serious cardiopulmonary reactions after people were injected with either of the products.
Definity had 2006 sales of about $65 million. Optison was recalled by GE Healthcare in November 2005 because of manufacturing problems. The company hoped to relaunch the product in 2007. The products are made from gases enclosed in tiny capsules of protein or fatty material. They can help doctors visualize the borders of the heart more clearly and identify abnormalities.
Definity and Optison Legal Help
If you or a loved one has suffered heart damage in this case, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.Published on Oct-18-07
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