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Drug's Risk Notice Is Slow To Arrive

Apr 25, 2004 | Pioneer Press

Millions of U.S. patients taking a potentially risky heart medication may not get the promised government warnings with their prescriptions until the end of the year, a drug manufacturer said last week.

The drug, amiodarone, is widely used by doctors to treat heart rhythm disorders such as atrial fibrillation and atrial flutter, purposes never approved by the U.S. Food and Drug Administration.

Many patients some left blind or with severely damaged lungs say doctors or pharmacists never told them about the drug's life-threatening side effects or that the FDA hadn't approved the treatment as safe and effective.

A top FDA official said last October, in response to an investigation by Knight Ridder newspapers, that the agency would take the rare action of requiring that all amiodarone prescriptions be dispensed with a special patient medication guide detailing the drug's dangers and what conditions it's approved to treat. Patients would start getting the FDA-approved guides by early 2004, the agency's top drug regulator, Dr. Janet Woodcock, said at the time.

Six months later, the guide is still under development and neither the FDA nor the drug manufacturer would say when it would be distributed.

"We're in the midst of that project," said Doug Petkus, a spokesman for Wyeth, which makes Cordarone, a brand-name version of the drug.

The FDA wrote Wyeth on Dec. 19 and asked the company to draft a patient medication guide for Cordarone tablets, Petkus said Wednesday. Petkus said it could take as long as a year and a half for the guide to be drafted and then gain FDA approval. He wouldn't say when the guide will be done.

Dr. Doug Throckmorton, the director of the FDA's division of cardio-renal drug products, wouldn't comment on Wyeth's time frame, other than to say "the agency is interested in having this done right and having it done in as timely a fashion as it can."

In the past, other companies have been able to distribute medication guides to consumers in less than six months.

Amiodarone can be highly toxic to patients and causes a wide range of serious side effects. In some studies, as many as 17 percent of patients have experienced lung damage with 10 percent dying from it. Others have suffered liver problems and blindness.

Rarely do doctors inform patients of off-label prescribing, which means using a drug in ways the FDA never approved. While legal, such use can upset the balance between risk and benefit that's crucial to get a drug approved and on the market.

Because of the side effects, the FDA approved the drug only to treat life-threatening heart conditions called ventricular tachycardia and ventricular fibrillation, and only after other drugs have failed.

Yet in the past year, doctors wrote nearly 2.3 million prescriptions for amiodarone to treat atrial fibrillation and other unapproved conditions accounting for 82 percent of it sales, according to a Knight Ridder analysis of drug industry data published last fall.

The FDA wouldn't say if other makers are drafting a guide. Officials at Upsher-Smith Laboratories in Maple Grove, Minn., which sells Pacerone, had no comment.

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