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    Wednesday, November 24, 2004

    Next! Another day, another FDA drug controversy:

    A highly toxic heart drug continues to be prescribed to millions of patients nationwide without the detailed consumer warnings prom-ised by the U.S. Food and Drug Administration more than a year ago.

    Each bottle of the drug, amiodarone -- sold under the brand names Cordarone and Pacerone as well several generics -- is supposed to include a new advisory that warns of its risks and symptoms of fatal side effects and explains how the medication is supposed to be used. But the advisory, planned since October 2003, remains in draft form, bouncing back and forth between the FDA and the drug maker assigned to write it.

    Why is it left to the manufacturer to write the warning? Shouldn't the FDA do it?

    Amiodarone is a fairly toxic medication. It's approved for treating ventricular arrhythmias, which can be deadly. But in the late 1990's it gained some favor as a treatment for recalcitrant atrial fibrillation, a much more common but less deadly arrhythmia. At the time, there was some controversy over whether it was best to let the heart beat irregularly and just slow down its rate or to try to convert it to a regular rhythm. One way to change the rhythm is shock therapy. Amiodarone provided a potential alternative to that, or in many cases, an adjunct.

    The conventional wisdom has swung in favor of controlling the rate. It's very difficult in many cases to convert atrial fibrillation to a normal rhythm. It's often the result of worn out heart tissue in the elderly, and it's just impossible to get it to work correctly. And yet, amiodarone does seem to be used for this, at least according to Knight-Ridder:

    According to recent data, doctors wrote more than 2 million prescriptions in a single year for atrial fibrillation and other heart conditions that amiodarone wasn't approved to treat. A Knight Ridder investigation last year found that those prescriptions represented 82 percent of all the amiodarone dispensed from retail pharmacies during the 12-month period ended July 31, 2003.

    Earlier this month, a class-action lawsuit was filed in New Jersey that accuses drug makers of promoting amiodarone for common heart ailments in an effort to boost profits. The suit contends that more than 1,000 people have died, 100 have had vision problems and thousands of others have suffered severe medical complications.

    I'm not sure how they knew what conditions the amiodarone prescriptions were meant to treat. Doctors don't usually write diagnoses on their prescriptions. But I've seen a dramatic decrease in amiodarone use for atrial fibrillation by the cardiologists in our area over the past couple of years. I suspect that most cardiologists are using it appropriately.


    posted by Sydney on 11/24/2004 08:01:00 AM 0 comments


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