Warnings of Amiodarone Risks for Heart Patients
After a delay of more than a year, the FDA has approved the publication of new warnings for a potentially risky heart drug taken by millions of Americans.
Patients taking amiodarone (Cordarone medication, Wyeth) were expected to be able to read the new warnings on the Internet beginning in mid-December. They will receive paper copies when they fill or refill prescriptions. The FDA has recently been under fire for failing to protect consumers from dangerous drugs.
It is not known why the guide, planned since October 2003, was delayed. As of this writing, the guide was undergoing final editing and Wyeth was working on getting printed copies of the guides to pharmacists. Patients will be able to view the final versi.
Amiodarone has been associated with numerous side effects, including lung toxicity, thyroid problems, and liver damage. Because of its dangers, generic amiodarone was approved only as a drug of last resort for specific life-threatening ventricular arrhythmias. Over time, however, it gained favor with cardiologists for the treatment of atrial fibrillation, a less serious heart rhythm condition.
Physicians wrote more than two million prescriptions in a single year for atrial fibrillation and other heart conditions that amiodarone was not approved to treat. For the year ending July 31, 2003, 82% of the drug’s retail sales were for unapproved uses, according to a Knight Ridder analysis.
Although many cardiologists defend amiodarone’s “off-label” use for atrial fibrillation, a National Institutes of Health study challenged their long-held beliefs. The study found that less risky drugs could be as effective as amiodarone.
