Bristol-Myers complies with FDA ruling concerning Definity

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Bristol-Myers Squibb (BMS) Medical Imaging sent a letter to healthcare professionals informing them of new FDA-issued safety information regarding its ultrasound contrast, Definity, pertaining to serious cardiopulmonary reactions, including fatalities.

As of Sept. 30, a total of 99 cases of serious cardiopulmonary reactions have been reported to the company. In post-marketing use, four patients experienced fatal cardiac arrests either during or within 30 minutes of Definity administration.

BMS Medical Imaging notified physicians of the following updated safety information:

Advice to physicians regarding serious cardiopulmonary reactions with Definity:

  • Serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following Definity administration.
  • Patients should be assessed for the presence of any condition that precludes Definity administration.
  • Patients should be monitored during and for 30 minutes following Definity administration, including vital sign measurements and electrocardiography in all patients and cutaneous oxygen saturation in patients at risk of hypoxemia.
  • Resuscitation equipment and trained personnel should be readily available during Definity administration.

Conditions that preclude the administration of Definity include:

  • Worsening or clinically unstable congestive heart failure;
  • Acute myocardial infarction or acute coronary syndromes;
  • Serious ventricular arrhythmias or high risk for arrhythmias;
  • Respiratory failure;
  • Severe emphysema, pulmonary emboli or conditions that cause pulmonary hypertension; and
  • Caution should be used with respect to the administration of Definity with exercise stress or pharmacologic stress agents (e.g. IV dipyridamole).

BMS Medical Imaging said it remains committed to providing current and accurate information available for its products.