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Warnings delayed for heart drug with high rate of off-label use
By Alison Young
Knight Ridder Newspapers
WASHINGTON - 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 last 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."
Woodcock, who said last fall that she didn't anticipate any delays in getting the warning out to patients, didn't respond to requests for an interview. But in a statement, she said, "We will turn this around very promptly since we view it as a priority."
In the past, other companies have been able to distribute medication guides to consumers in less than six months.
"It's really important for us to get this one right," Throckmorton said Wednesday. "As you pointed out, there is some substantial off-label use and people asking whether patients fully understand all the toxicity."
Off-label prescribing involves a doctor using a drug in ways the FDA never approved and therefore aren't listed on its label, the official listing of prescribing information. While going off-label is legal, such use can upset the balance between risk and benefit that's crucial to get a drug approved and on the market. Rarely do doctors inform patients when a prescription is for an unapproved purpose.
Amiodarone can be highly toxic to patients and causes a wide range of serious and life-threatening side effects. As many as 17 percent of patients in some studies have experienced lung damage - with 10 percent dying from it. Others have suffered thyroid, liver and eye problems, including blindness.
Because of the drug's significant side effects, the FDA approved it only as a treatment for life-threatening heart conditions called ventricular tachycardia and ventricular fibrillation, and only as a treatment of last resort 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 all amiodarone prescriptions, according to an exclusive Knight Ridder analysis of drug industry data published last fall.
Throckmorton said patients who take amiodarone should discuss the risks and benefits of the therapy with their doctors. Patients can also request a copy of the FDA-approved prescribing information from their pharmacist, although the language in the pamphlet is aimed at doctors and is highly technical.
A major National Institutes of Health study, called AFFIRM, found in December 2002 that less risky drugs could be used to effectively treat atrial fibrillation. Yet many cardiologists continue to favor amiodarone.
Larry Sasich, a pharmacist and analyst at Public Citizen's Health Research Group in Washington, said it's impossible to know whether Wyeth is dragging its feet on the guide. "The longer that it takes for the MedGuide to be written and to be distributed, the less consumers know, and so it's possible to sell more drugs," Sasich said Thursday.
"Given the toxicity of the drug, of which there is no question, and that the drug remains among the top 200 most frequently prescribed generic drugs in the United States, it's really disturbing that reliable information is not in the hands of patients," he said.
Sue Nelson, a 50-year-old registered nurse in Syracuse, N.Y., has urged the FDA for years to require amiodarone patients be given a medication guide. As recently as last September, an FDA official wrote back that the agency saw no need for one. Nelson's mother and brother-in-law died from lung toxicity after taking amiodarone for atrial fibrillation.
"Why did it take so long? They've had victims write them letters for years," Nelson said. "I think the FDA has a lot of questions to answer for looking the other way."
Nelson, who's posted information about amiodarone's dangers on the Internet, regularly gets e-mails from patients and their families. "If they get a MedGuide that tells them what this drug can do to them, they're going to be incredibly angry," she said.
FDA officials wouldn't say whether Wyeth, based in Madison, N.J., is the only amiodarone manufacturer working on a draft of the medication guide. Officials at Upsher-Smith Laboratories in Maple Grove, Minn., which sells the drug under the brand name Pacerone, said they had no comment.
The drug is also sold by several generic manufacturers. Once a guide is approved by the FDA, it will be distributed with all amiodarone prescriptions, regardless of who made the pills.
By Alison Young
Knight Ridder Newspapers
WASHINGTON - 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 last 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."
Woodcock, who said last fall that she didn't anticipate any delays in getting the warning out to patients, didn't respond to requests for an interview. But in a statement, she said, "We will turn this around very promptly since we view it as a priority."
In the past, other companies have been able to distribute medication guides to consumers in less than six months.
"It's really important for us to get this one right," Throckmorton said Wednesday. "As you pointed out, there is some substantial off-label use and people asking whether patients fully understand all the toxicity."
Off-label prescribing involves a doctor using a drug in ways the FDA never approved and therefore aren't listed on its label, the official listing of prescribing information. While going off-label is legal, such use can upset the balance between risk and benefit that's crucial to get a drug approved and on the market. Rarely do doctors inform patients when a prescription is for an unapproved purpose.
Amiodarone can be highly toxic to patients and causes a wide range of serious and life-threatening side effects. As many as 17 percent of patients in some studies have experienced lung damage - with 10 percent dying from it. Others have suffered thyroid, liver and eye problems, including blindness.
Because of the drug's significant side effects, the FDA approved it only as a treatment for life-threatening heart conditions called ventricular tachycardia and ventricular fibrillation, and only as a treatment of last resort 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 all amiodarone prescriptions, according to an exclusive Knight Ridder analysis of drug industry data published last fall.
Throckmorton said patients who take amiodarone should discuss the risks and benefits of the therapy with their doctors. Patients can also request a copy of the FDA-approved prescribing information from their pharmacist, although the language in the pamphlet is aimed at doctors and is highly technical.
A major National Institutes of Health study, called AFFIRM, found in December 2002 that less risky drugs could be used to effectively treat atrial fibrillation. Yet many cardiologists continue to favor amiodarone.
Larry Sasich, a pharmacist and analyst at Public Citizen's Health Research Group in Washington, said it's impossible to know whether Wyeth is dragging its feet on the guide. "The longer that it takes for the MedGuide to be written and to be distributed, the less consumers know, and so it's possible to sell more drugs," Sasich said Thursday.
"Given the toxicity of the drug, of which there is no question, and that the drug remains among the top 200 most frequently prescribed generic drugs in the United States, it's really disturbing that reliable information is not in the hands of patients," he said.
Sue Nelson, a 50-year-old registered nurse in Syracuse, N.Y., has urged the FDA for years to require amiodarone patients be given a medication guide. As recently as last September, an FDA official wrote back that the agency saw no need for one. Nelson's mother and brother-in-law died from lung toxicity after taking amiodarone for atrial fibrillation.
"Why did it take so long? They've had victims write them letters for years," Nelson said. "I think the FDA has a lot of questions to answer for looking the other way."
Nelson, who's posted information about amiodarone's dangers on the Internet, regularly gets e-mails from patients and their families. "If they get a MedGuide that tells them what this drug can do to them, they're going to be incredibly angry," she said.
FDA officials wouldn't say whether Wyeth, based in Madison, N.J., is the only amiodarone manufacturer working on a draft of the medication guide. Officials at Upsher-Smith Laboratories in Maple Grove, Minn., which sells the drug under the brand name Pacerone, said they had no comment.
The drug is also sold by several generic manufacturers. Once a guide is approved by the FDA, it will be distributed with all amiodarone prescriptions, regardless of who made the pills.
