Research shows that microbubble contrast agents sold under the trade names Definity and Optison can cause heart-related side effects.
What Are Microbubble Contrast Agents? What Are They Used For?
Cardiologists inject microbubble contrast agents into patients who then undergo ultrasound echocardiograms. The agents alter the ways the ultrasound’s waves reflect off internal organs, allowing doctors to better see the left ventricular endocardial border and opacify the left ventricular chamber. The clearer picture helps cardiologists diagnose their patients.
The U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb’s Definity in mid-2001. Definity contains 6.52 mg/mL perflutren (octafluoropropane) inside a lipid shell. General Electric Healthcare’s Optison, approved in late 1997, uses an albumin shell over a 10mg/mL octafluoropropane gas core.
Potential Definity and Optison Side Effects
In October 2007, the FDA required GE and Bristol Myers to add a “black box” warning to their respective products’ packages. The substances caused severe cardiac reactions in patients, often within the first 30 minutes of injection. The 200 adverse reports the FDA received until then included 11 fatalities, out of which 4 occurred within that 30-minute time period.
The black box warnings recommended that patients with high risks of pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored until 30 minutes after receiving the microbubble contrast agent injection with resuscitation equipment on standby for severe cases. The FDA also required manufacturers to conduct clinical studies on the contrast agents.
The FDA added the following contraindications to microbubble contrast agents: fixed right-to-left bi-directional cardian shunts or transient right-to-left shunts. The agency also warned against intra-arterial injection of Definity or Optison.
After the 2007 warning, the FDA received reports of 5 deaths of patients injected with Definity, though they all already had severe heart conditions. The FDA received 60 other reports of non-fatal reactions to Definity and none for Optison. In 2008, the FDA removed some contraindications for heart conditions deemed so severe that the potential benefits outweighed the risks.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a microbubble contrast agent lawsuit on your behalf if necessary.
If you have had a microbubble contrast agent injected and believe it harmed you, contact RLG today.