Definity / Optison

Definity and Optison are contrasting agents that are used during echocardiograms to provide a clearer picture of the heart. During an echocardiogram, the contrasting agent is injected into the patient’s bloodstream. The drug is made of microscopic gas-filled spheres that sharpen the results of the echocardiogram image. This allows doctors to more easily identify and diagnose heart defects and malfunctions. Definity and Optison should not be used if the patient has a history of certain heart problems, because these drugs have been linked to sometimes fatal heart and lung problems. Bristol Myers Squibb marketed Definity, while Optison was distributed by General Electric.

In 2007, the FDA had reports of 11 deaths that occurred after patients took these drugs. Four of the fatalities occurred only 30 minutes after injection, and the FDA concluded that most serious reactions happened during that time frame. After hundreds of reports of serious cardiac reactions and deaths as a result of Definity and Optison injections, the FDA asked the manufacturer to place a black box warning on packaging. The black box warning states that contrasting agents should not be given to patients with right-to-left, bi-directional, or transient right-to-left cardiac shunts, congestive heart failure, acute myocardial infarction, serious ventricular arrhythmias, respiratory failure, severe emphysema, pulmonary emboli and more. This warning also advised physicians to monitor patients who had been administered the drug for 30 minutes following the procedure, and keep resuscitation equipment on hand for the entirety of that time.

Common side effects may include:

• Dizziness
• Flushing
• Headache
• Nausea

More severe side effects may include:

• Chest pain
• Fainting
• Fever
• Irregular heartbeat
• Numbness or pain of the arm , leg, or back
• Seizure
• Shortness of breath
• Sudden severe headache, dizziness, nausea, or vomiting
• Back pain
• Chest, jaw, or arm pain
• Confusion
• Decreased feeling in the face
• Fever, chills, or persistent sore throat
• Loss of consciousness
• One-sided weakness
• Slurred speech
• Sudden, severe nausea or vomiting
• Swelling of the hands, ankles, or feet
• Unusual sweating
• Vision changes (eg, blurred vision)
• Weakness
• Wheezing