After a Long Delay, FDA Approves Warnings for Heart Drug

Dec. 8–WASHINGTON — After a delay of more than a year, the Food and Drug Administration has approved publication of new patient warnings for a potentially risky heart drug that millions of Americans are taking.

Patients taking amiodarone can read the new warnings on the Internet beginning next week and will soon start receiving paper copies when they get or refill prescriptions. The FDA’s action comes two weeks after Knight Ridder reported the delay, prompting an outcry from readers who said they’ve lost loved ones or suffered side effects from the drug, and as the agency is under fire for failing to protect consumers from dangerous drugs.

FDA officials had no comment Tuesday. The agency hasn’t responded to Knight Ridder’s repeated requests for information about why publication of the amiodarone medication guide — planned since October 2003 — has taken so long.

The guide is undergoing a final edit and will be posted on the Web sometime next week, said Chris Garland, a spokesman for Wyeth, the drug maker assigned to write it. Patients will be able to read it at www.wyeth.com, he said. Details of the guide’s contents weren’t available Tuesday.

In general, such guides contain detailed warnings about potential side effects, how the drug should be used and what conditions the FDA has approved it to treat. Amiodarone, also sold under the brand names Cordarone and Pacerone, has numerous serious and fatal side effects, including lung toxicity, thyroid problems and liver damage.

Because of its dangers, the FDA approved amiodarone only as a drug of last resort for specific life-threatening heart rhythm conditions, called ventricular arrhythmias. But over time, it’s gained favor with cardiologists as a treatment for atrial fibrillation, a common and less serious heart rhythm condition it was never approved to treat.

According to recent pharmaceutical industry data, doctors wrote more than 2 million prescriptions in a single year for atrial fibrillation and other heart conditions the drug wasn’t approved to treat. For the year ending July 31, 2003, 82 percent of the drug’s retail sales were for unapproved uses, a Knight Ridder analysis found last year.

While many cardiologists defend amiodarone’s “off-label” use for atrial fibrillation, a recent National Institutes of Health study challenged their long-held beliefs. Called AFFIRM, the study found that less risky drugs that control a patient’s heart rate can be as effective as rhythm control drugs such as amiodarone.

In response to a Knight Ridder investigation, which found that patients routinely got little information about the drug’s risks and alternative therapies, the FDA in October 2003 said it would require an amiodarone medication guide. The agency’s top drug regulator said at the time that the guide would begin being distributed to patients by early 2004.

Garland said that Wyeth, which sells the drug as Cordarone, is still working out plans to get printed copies of the guide to pharmacies, where it will be distributed with all new and refill prescriptions. He said he expects printed copies to be available within several weeks.

It will be up to the FDA to determine how this information will be distributed to patients taking versions of the drug made by several generic manufacturers, Garland said. FDA officials didn’t respond to requests for information about this.

“This was put together on a very aggressive timetable,” Garland said, noting that the FDA didn’t ask Wyeth to develop the guide until Dec. 19, 2003. At that time, he said, Wyeth told the FDA it would take a year to compete the project — and the company finished early.

The warnings aren’t coming soon enough for families harmed by the drug.

Carol Holcomb said her mother died of pulmonary fibrosis in September after taking amiodarone for about two years as a treatment for atrial fibrillation. The lung condition is one of the most lethal side effects of the drug.

“I realize it’s an effective drug, but the people taking it have to know the risks and I don’t think they do. And I don’t think the doctors are very aware of them either,” said Holcomb, who lives in the Philadelphia suburb of Flourtown.

When her mother, Anna May Gerstlauer, first went to the hospital with breathing problems, Holcomb said doctors thought she had pneumonia. Only later, when she got worse, was the drug suspected. Gerstlauer turned 78 in the hospital and died while on a respirator, her daughter said.

Larry Sasich, a pharmacist and analyst at Public Citizen’s Health Research Group in Washington, said amiodarone becomes one of just 15 or so drugs that the FDA has required to carry government-approved patient information. Most of the drug information routinely distributed by pharmacies via printouts is commercially written and varies in quality, government studies have found.

“What I hope the impact will be is that patients ask their physicians hard questions about whether or not I really need this,” Sasich said. “Do I need a drug that’s not approved for the condition I have where there are substantial risks?”

The warning will be available starting next week at www.wyeth.com

To report possible adverse drug reactions, go to: www.fda.gov/medwatch/how.htm or call 1-888-463-6332.

To read previous Knight Ridder reports on amiodarone, go to www.krwashington.com and click on “Risky Rx”.

FREQUENTLY ASKED QUESTIONS ABOUT AMIODARONE: WASHINGTON — Here are some frequently asked questions about the heart drug amiodarone.

QUESTION: What are amiodarone’s risks?

ANSWER: The drug’s FDA-approved prescribing label for doctors, which patients rarely see, warns that the drug comes with “substantial toxicity.”

–Lung toxicity, which has harmed as many as 17 percent of patients in some studies and has been fatal about 10 percent of the time.

–When given to pregnant women, the drug has caused serious harm to the fetus.

–Other side effects include thyroid problems, liver injury, worsening of heart rhythm problems and neurological disorders. Vision problems and blindness also have been reported.

Q: Should patients take amiodarone for atrial fibrillation?

A: The FDA hasn’t approved amiodarone to treat atrial fibrillation. However, as with all drugs, doctors are free to prescribe it “off label” after weighing the risks and benefits.

According to the latest research, particularly a major National Institutes of Health study called AFFIRM, experts say amiodarone generally isn’t the first drug a patient should try for atrial fibrillation. A patient should first try a drug to regulate how fast the heart beats.

Other options include a procedure to destroy the misfiring electrical connection in the heart. Patients also can be treated with various rhythm-control drugs.

Q: What can patients do?

A: Beginning sometime next week, a copy of the new FDA-approved patient guide for amiodarone will be available on the Web from the manufacturer of the brand-name version of the drug, Cordarone. Go to www.wyeth.com.

–In the meantime, ask your pharmacist for a copy of the official, FDA-approved prescribing label — not just the one-page sheet that pharmacies often hand out with drugs. Or read the label online at www.cordarone.com

–Talk with your doctor. Ask why he or she chose rhythm control over rate control. For more information about the AFFIRM study, go to http://www.nhlbi.nih.gov/new/press/02-12-04.htm

–Don’t stop taking amiodarone without a doctor’s supervision.

— Make sure your doctor regularly monitors you for signs of lung, liver and thyroid problems.

–To read other Knight Ridder articles about amiodarone, go to www.krwashington.com and click on “Food and Drug Administration coverage.”

Q: How do I report an adverse drug reaction?

A: Go to www.fda.gov/medwatch/how.htm or call 1-888-463-6332.

—–

(c) 2004, Knight Ridder. Distributed by Knight Ridder/Tribune Business News. For information on republishing this content, contact us at (800) 661-2511 (U.S.), (213) 237-4914 (worldwide), fax (213) 237-6515, or e-mail reprints@krtinfo.com.

KRI, WYE,