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Definity and Optison Contrast Agents
On July 17, 2008, the US Food and Drug Administration (FDA) updated its warning regarding Definity and Optison, the only micro-bubble contrast agents approved for use in the United States. They are used to improve the definition of certain echocardiograms (sonogram images of the heart). Echocardiography is one of the most widely used diagnostic tests for heart disease.
The update alerts healthcare professionals about changes in the prescribing information for the Definity and Optison contrast agents. The Boxed Warning and Warnings sections of the prescribing information continue to emphasize the risk of serious cardiopulmonary reactions while being administered the agents or up to 30 minutes thereafter. They also recommend that high-risk patients with unstable cardiopulmonary conditions or with pulmonary hypertension be closely monitored during or within 30 minutes following the administration of these contrast agents.
Some of the contraindications (conditions which make the administration of these agents unadvisable) that were added to the labeling in October, 2007 were also removed because it was determined that the benefits to some patients from the diagnostic information gained through the use of Definity or Optison may outweigh the risks involved.
The FDA update also indicated that it is requiring the makers of Definity and Optison contrast agents to conduct clinical studies to more thoroughly evaluate the risks for serious cardiopulmonary reactions.
The update advises patients slated to undergo echocardiography to tell their physician if they:
- Have a congenital heart defect
- Have a lung or heart condition that has recently worsened
- Have a condition that has caused high blood pressure in the blood vessels that go into their lungs
- Ever had reaction to a drug that was given to them during an echocardiogram
If you or a loved one has been injured as a result of having been administered a Definity or Optison contrast agent, you may be entitled to compensation. Contact a qualified pharmaceutical injury attorney for an evaluation of your case.