As a result, Robert's family has filed a medical malpractice lawsuit against the prescribing doctor, alleging wrongful death. The basis of the lawsuit is that Robert should not have been put on amiodarone because he did not have ventricular fibrillation—for which the drug is approved—and because the prescribing doctor did not attempt to put Robert on other medications before prescribing the amiodarone. Following her father's death, Diane has researched amiodarone extensively and wants to get information about this drug out to the public.
In May 2005, the FDA sent out an alert about amiodarone, warning that the drug could cause fatal pulmonary toxicity (lung toxicity), hepatic injury and worsened arrhythmia. The FDA further warned that amiodarone should only be used to treat adults with life-threatening ventricular arrhythmias when other treatments have not worked or cannot be tolerated (fda.gov). In making the announcement, the FDA cited studies that found pulmonary toxicity rates as high as 17 percent in some patients. According to the FDA, pulmonary toxicity is fatal 10 percent of the time.
"The doctor used amiodarone to treat atrial fibrillation in my father, which is an off-label use of the drug according to the FDA," Diane says. "There are a few amiodarone side effects, including thyroid problems and liver problems, but the most serious consequence is the lung damage [lung toxicity, also known as pulmonary toxicity], which is what killed my father.
"My father didn't even have a bad atrial fibrillation. He'd only had two episodes and they were both paroxysmal, meaning they stopped on their own. He didn't require medical intervention to stop the episodes. So, amiodarone was a serious drug for him to be put on to start with.
"After that, it was a calamity of errors. The doctor prescribed the amiodarone, which was an error, at the same time he was given a pacemaker. He recommended my father have bypass surgery. We found out about robotic bypass, which was less harmful than other bypass because they don't break the sternum and there is a shorter recovery time. So, we researched robotic surgeons and my father wound up going to the second-most experienced robotic surgeon in the US.
"My father was put on amiodarone for four months before the bypass surgery. The robotic surgeon took him off the medication five days before the surgery. That was an error. Amiodarone has a half-life of at least 20 days, with an average half-life of around 50 days. So, my father should have been taken off it a minimum of 60 days before the surgery.
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"How could this happen? He was chopping wood a week before the pacemaker was put in [the same time the amiodarone was prescribed]. He was healthy. The surgery was voluntary, it wasn't mandated. We could have put it off because he didn't need it immediately. If he hadn't had the surgery, he wouldn't have died. I don't think the doctor knew about the half-life of the amiodarone. We asked the doctor about the risks prior to the surgery, but all he said was, 'There are always some risks'.
"My father went into the hospital on May 15, 2007, for his surgery and he never came out."