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The FDA issued an updated alert about the dangers of using micro-bubble contrast agents for diagnosis in certain patients.
The FDA has issued an updated alert about the dangers of using micro-bubble contrast agents for diagnosis in certain patients with suboptimal echocardiograms. The agency said warnings on the product alert health professionals to the risk of serious cardiopulmonary reactions during or within 30 minutes of administration of these products. High-risk patients with pulmonary hypertension or unstable cardiopulmonary conditions should be closely monitored during and for at least 30 minutes after the products are given. Another change FDA made is in the section dealing with contraindications. The agency said it has concluded that for some patients, the benefits from using Definity or Optison may outweigh the risk of serious cardiopulmonary reactions. So it has removed some contraindications in the labeling to reflect this finding.