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Heart Drug Guide Indicating Risks Misses Deadline

Nonapproved use of medicine usual

Apr 23, 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 this 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 they were never told by doctors or pharmacists about the drug's life-threatening side effects or that the FDA hadn't approved their treatment as safe and effective.

A top FDA official said in October, in response to an investigation by Knight Ridder, that the agency would take the rare action of requiring 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 a major drug manufacturer that's drafting the guide would say when it would be distributed to consumers.

"We told them we would do it, but it takes almost a year to complete it. We're in the midst of that project," said Doug Petkus, a spokesman for Wyeth, the maker of Cordarone, a brand-name version of the amiodarone 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 go through an FDA review and approval process.

He wouldn't say when the company expects to complete the guide.

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."