Popular prescription heart drug now comes with a danger warning

WASHINGTON – Millions of Americans who pick up their prescriptions for a popular heart drug will get a new pamphlet, released Monday, that warns of the many dangers associated with the drug’s use.

The new patient medication guide for amiodarone was required by the U.S. Food and Drug Administration after officials learned that doctors weren’t informing patients of the drug’s serious risks. The drug is prescribed widely for common heart ailments despite being approved only as a drug of last resort for more serious conditions.

The new information, which was posted Monday on two drug makers’ Web sites, says in bold letters that the “most important information” consumers should know is that the drug “can cause serious side effects that can lead to death, including lung damage, liver damage, worse heartbeat problems.”

Amiodarone becomes one of only a handful of drugs that the agency has required to be dispensed with such a patient guide. The FDA-approved language in the guide is stronger and more direct than what patients often receive from their pharmacies or doctors.

The FDA required the guide’s creation in response to a Knight Ridder investigation, published in November 2003, that found that patients routinely got little information about the drug’s risks and safer alternative therapies.

“I think that it will certainly stimulate a lot of questions from the patients, which is good,” said Dr. Frank Pelosi, a heart rhythm specialist and director of electrophysiology at the University of Michigan Cardiovascular Center in Ann Arbor.

Other cardiologists said the guide may alarm patients and may change the way doctors prescribe the drug out of concerns about possible legal liability.

The FDA approved amiodarone nearly 20 years ago as a drug of last resort for specific life-threatening heart rhythm conditions, called ventricular arrhythmias.

Over time, though, it’s gained favor with cardiologists as an “off-label” treatment for atrial fibrillation, a common and less serious heart rhythm condition it was never approved to treat. Doctors say the drug is an important treatment for some patients despite its risks.

According to recent pharmaceutical industry data, doctors wrote more than 2 million amiodarone prescriptions in a single year for atrial fibrillation and other off-label conditions. For the 12-month period ending July 31, 2003, 82 percent of the drug’s retail sales were for unapproved uses, a Knight Ridder analysis found last year.

The new medication guide notifies patients that amiodarone “should only be used in adults with life-threatening heartbeat problems called ventricular arrhythmias, for which other treatments did not work or were not tolerated.”

Such language concerns Dr. Steven Whitfield, a cardiologist in Olathe, Kan.

“Essentially by putting that in there, the company is, to my way of thinking, taking amiodarone out as a drug option for treating atrial fibrillation,” Whitfield said. He said his practice at Olathe Medical Center is evaluating the guide’s legal implications and might develop its own consent form.

Whitfield said the guide does a good job of alerting patients of drug interaction problems and the need to undergo regular lung, blood and vision tests.

The guide is available only on the Internet, but a paper version will be distributed soon with all new and refill prescriptions of brand-name and generic versions of the drug.

Many patients take generic versions that are made by a variety of companies. FDA officials didn’t return calls Monday about when patients can get the guides from their pharmacists.

Mark Robbins, a vice president at Upsher-Smith in Minneapolis, said distribution of copies of the guide for its brand-name version of the drug, called Pacerone, to pharmacies is “imminent. … I would think a matter of days.”

Wyeth officials in Madison, N.J., couldn’t be reached Monday, but have said it could be a few weeks before its guide for its brand-name version, Cordarone, is distributed.

“I am very happy with the med-guide. It will save many lives,” said Sue Nelson of Syracuse, N.Y., who for years has urged the FDA to require one.

Nelson’s mother died of lung toxicity after taking amiodarone for atrial fibrillation.

“The first bold-faced warning on the med-guide would have been enough to save my mother’s life,” she said.