Definity Linked To Patient Deaths During Echocardiograms, Says FDA
As we have previously discussed, several drugs have been found to negatively impact patients with heart issues. In March, 2008, we discussed the Trasylol crisis covered on 60 Minutes, which led to the negligent deaths of many heart surgery patients.
Today, it appears that the drug known as “Definity” is being investigated by the FDA. According to the Associated Press, “Despite previous warnings to physicians, drugs used to improve medical images of the heart continue to cause fatal side effects. The FDA said that since October it has received four reports of patients dying after receiving injections of the drug Definity. One patient with congestive heart failure died within five minutes of receiving the drug.”
Obviously, this is terrible news. And, I imagine that many of you are wondering, “What is Definity?”
So you know, Definity is used to help make the heart and heart function easier to see during certain diagnostic procedures including echocardiograms. According to Drugs.com, Definity is a contrast agent. It works in the blood to help create a clearer picture of the heart. The agents contain tiny gas bubbles that help doctors spot small clots and other potential heart problems.
The Associtaed Press report noted that the FDA in October placed its most serious warning on imaging drugs (e.g. Definity) after receiving about 200 reports of serious allergic reactions, seven of which caused death.
Definity was previously marketed by Bristol-Myers Squibb Co. until December, 2007 when the drug was sold to privately held Lantheus Medical Imaging, which is based in North Billerica, Mass.
General Electric Co. markets a similar drug called Optison. But the FDA said it recorded fewer safety problems with Optison because GE stopped selling it between 2005 and 2007.
The FDA released updated information on negative side effects reported with the drugs ahead of a meeting next week. Next, the agency will ask a panel of outside experts to suggest safety requirements for developing better, safer imaging products.
Keep on tickin (without Definity),
Adam Pick is a double, heart valve surgery patient and author of The Patient’s Guide To Heart Valve Surgery, a unique book which integrates the clinical facts of heart valve surgery with the personal experiences of an actual heart valve surgery patient. To learn more about Adam and his heart valve surgery book, click here.
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