This article is over two years old and I'm sorry if someone has posted it already but as we on VR.com age, a good percentage of us have or will have AF. You should be warned about the problem with this drug.
Posted on Tue, Nov. 23, 2004
Millions unaware of heart drug risk, FDA slow to deliver promised warning for amiodarone
By Alison Young
Knight Ridder Newspapers
Is your drug off-label?
About this series
A highly toxic heart drug continues to be prescribed to millions of patients nationwide without the detailed consumer warnings promised by the U.S. Food and Drug Administration more than a year ago.
Bottles of the drug, amiodarone, are supposed to include an advisory that warns of its many risks, lists symptoms of fatal side effects and explains how the medication is supposed to be used. But the advisory, planned since October 2003, remains in draft form, bouncing back and forth between the FDA and the drug maker assigned to write it.
FDA officials didn't respond to requests for interviews about amiodarone and its efforts to protect consumers. An FDA spokeswoman instead referred questions to Wyeth, the drug maker.
Wyeth spokesman Chris Garland said the FDA could approve its advisory as early as next month. Wyeth, which sells the drug under the brand name Cordarone, was given the job of writing the informational guide because it was the first company to sell the drug.
Amiodarone is sold by several generic manufacturers, as well as under another brand name, Pacerone.
The warning delay comes as the FDA is being questioned about its slowness in protecting Americans from deadly drugs, including the arthritis drug Vioxx, which was pulled off the market this fall.
"How many people are dying right now as we speak as a result of their procrastination?" asked Karen Muccino of Los Alamitos, Calif., whose father died Feb. 20 of lung damage caused by amiodarone.
Despite his training as an obstetrician, Muccino's father never realized his dry cough was a symptom of a potentially fatal side effect, Muccino said. And she said she's livid that the FDA didn't immediately issue patient warnings last fall.
"He would have been taken off the drug three months earlier, and his life would have been saved," Muccino said.
Sen. Charles Grassley, chairman of the Senate Finance Committee, said Tuesday that he will look into the delays in the amiodarone warnings.
"What's happening with this drug goes to the heart of questions about how long it takes the FDA to act when known risks or dangers exist," the Iowa Republican said. "The FDA and drug companies might know about risks, but it doesn't do any good if doctors and patients don't know about them too."
Like most patients, Muccino's father was taking amiodarone for atrial fibrillation, a common condition in which the heart beats out of rhythm.
The FDA never approved the drug to treat that condition.
Patients taking amiodarone have died from lung and liver damage, gone blind or suffered other side effects. Yet it's routinely prescribed for common heart rhythm problems despite safer alternatives.
The FDA has approved amiodarone only for more severe disorders, called ventricular arrhythmias, and then only as a treatment of last resort.
According to recent data, doctors wrote more than 2 million prescriptions for amiodarone in a single year for atrial fibrillation and other heart conditions the drug wasn't approved to treat. A Knight Ridder investigation last year found that those prescriptions represented 82 percent of all the amiodarone dispensed from retail pharmacies during the 12-month period ending July 31, 2003.
This month, a class-action lawsuit was filed in New Jersey that accuses drug makers of promoting amiodarone for common heart ailments in an effort to boost profits. The suit contends that more than 1,000 people died, 100 had vision problems and thousands of others suffered severe medical complications.
When the FDA approved amiodarone for sale in the United States, it recognized that it was a dangerous drug and told doctors to be careful about its use.
Dr. Valentin Fuster, chairman of the American College of Cardiology's treatment guidelines committee for atrial fibrillation, said amiodarone shouldn't be the first drug a doctor tries when treating the disorder.
"You don't use amiodarone as a drug for this except after everything else fails," said Fuster, who also is director of the cardiovascular institute at Mount Sinai Medical Center in New York City. "Amiodarone carries a higher risk than other drugs."
Knight Ridder found that patients routinely were given little information about the drug's risks or alternative therapies. Over the years, the FDA has cited various manufacturers for playing down its risks and for promoting it as a first-line therapy.
In October 2003, Dr. Janet Woodcock, who at the time ran the FDA's drug division, said the agency would take the rare action of requiring the advisory in all amiodarone prescriptions.
Because of the dangers posed by the drug, Woodcock said the information would be written and distributed quickly, certainly by early 2004. "Obviously this drug is a very risky drug," she said then.
Woodcock, now the FDA's acting deputy commissioner for operations, didn't respond to requests for an interview over the past week.
The FDA first asked Wyeth to write the guide on Dec. 19, 2003, and the company gave the FDA a first draft Aug. 23. "That was in advance of what the FDA asked us and what we told them we would do," Wyeth spokesman Garland said. "We told them we would submit by November."
The FDA sent back its first comments on the guide Sept. 21, Garland said. Wyeth replied in October. The draft is now with the FDA, he said, adding that the process is happening quickly by drug regulation standards.
"Normally, the FDA can take up to six months to respond to an initial filing," Garland said.
In the lawsuit against Wyeth and several other makers of amiodarone, patients and their families accused the drug makers of pushing doctors to prescribe the drug for unapproved uses while concealing and playing down its risks.
"It's our belief there has been one long overpromotion of this drug," said David Harris, a Naples, Fla., attorney who filed the suit Nov. 10 in Atlantic County Superior Court in New Jersey. Officials at Wyeth, the lead defendant in the case, had no comment about the suit.
Karen Muccino is one of five plaintiffs. Her father, Dr. John Muccino, 69, had suffered from chronic atrial fibrillation since he was in his 40s, she said. When his heart was out of rhythm, it made him tired. He was put on various medications over the years with varying degrees of success. In October 2002, doctors put him on amiodarone, she said.
About a year later, he developed a dry cough. The cough worsened and by New Year's Day 2004 he was very ill with what he thought was a bad cold. Within days, he was hospitalized with what seemed to be pneumonia. A lung biopsy, however, found it was amiodarone lung damage, Karen Muccino said. Her father died after being taken off a respirator Feb. 20.
"There must be changes made and there must be some accuntabilitiy," said Muccino, a nurse by training and the vice president of a health care company. "There are so many medications that have labels on them saying 'Take with food or milk,' but you have a drug like this that has such slight warnings of an impending fatal situation and it isn't noted on the prescription bottle, which is totally ridiculous."
Users risk serious side effects:
What are amiodarone's risks?
The drug's FDA-approved prescribing label for doctors, which patients rarely see, warns that the drug comes with "substantial toxicity." About three-fourths of all patients taking a 400 mg dose experienced some side effects. Some can be fatal:
-- 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.
-- Liver injury is common. While usually mild, it can be fatal.
-- Worsening of the heart rhythm problem.
-- When given to pregnant women, the drug has seriously harmed the fetus.
Other side effects include thyroid problems and neurological disorders. Vision problems and blindness have been reported.
Should patients take amiodarone for atrial fibrillation?
The FDA hasn't approved amiodarone to treat atrial fibrillation. However, doctors are free to prescribe it "off label" after weighing the risks and benefits.
According to 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.
What can patients do?
-- Talk with your doctor. Ask why he or she chose rhythm control over rate control. For information about the AFFIRM study, go to 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.
-- Ask your pharmacist for a copy of the official prescribing label -- not just the single sheet that pharmacies often hand out with drugs. Or read the label online at www.cordarone.com.
Posted on Tue, Nov. 23, 2004
Millions unaware of heart drug risk, FDA slow to deliver promised warning for amiodarone
By Alison Young
Knight Ridder Newspapers
Is your drug off-label?
About this series
A highly toxic heart drug continues to be prescribed to millions of patients nationwide without the detailed consumer warnings promised by the U.S. Food and Drug Administration more than a year ago.
Bottles of the drug, amiodarone, are supposed to include an advisory that warns of its many risks, lists symptoms of fatal side effects and explains how the medication is supposed to be used. But the advisory, planned since October 2003, remains in draft form, bouncing back and forth between the FDA and the drug maker assigned to write it.
FDA officials didn't respond to requests for interviews about amiodarone and its efforts to protect consumers. An FDA spokeswoman instead referred questions to Wyeth, the drug maker.
Wyeth spokesman Chris Garland said the FDA could approve its advisory as early as next month. Wyeth, which sells the drug under the brand name Cordarone, was given the job of writing the informational guide because it was the first company to sell the drug.
Amiodarone is sold by several generic manufacturers, as well as under another brand name, Pacerone.
The warning delay comes as the FDA is being questioned about its slowness in protecting Americans from deadly drugs, including the arthritis drug Vioxx, which was pulled off the market this fall.
"How many people are dying right now as we speak as a result of their procrastination?" asked Karen Muccino of Los Alamitos, Calif., whose father died Feb. 20 of lung damage caused by amiodarone.
Despite his training as an obstetrician, Muccino's father never realized his dry cough was a symptom of a potentially fatal side effect, Muccino said. And she said she's livid that the FDA didn't immediately issue patient warnings last fall.
"He would have been taken off the drug three months earlier, and his life would have been saved," Muccino said.
Sen. Charles Grassley, chairman of the Senate Finance Committee, said Tuesday that he will look into the delays in the amiodarone warnings.
"What's happening with this drug goes to the heart of questions about how long it takes the FDA to act when known risks or dangers exist," the Iowa Republican said. "The FDA and drug companies might know about risks, but it doesn't do any good if doctors and patients don't know about them too."
Like most patients, Muccino's father was taking amiodarone for atrial fibrillation, a common condition in which the heart beats out of rhythm.
The FDA never approved the drug to treat that condition.
Patients taking amiodarone have died from lung and liver damage, gone blind or suffered other side effects. Yet it's routinely prescribed for common heart rhythm problems despite safer alternatives.
The FDA has approved amiodarone only for more severe disorders, called ventricular arrhythmias, and then only as a treatment of last resort.
According to recent data, doctors wrote more than 2 million prescriptions for amiodarone in a single year for atrial fibrillation and other heart conditions the drug wasn't approved to treat. A Knight Ridder investigation last year found that those prescriptions represented 82 percent of all the amiodarone dispensed from retail pharmacies during the 12-month period ending July 31, 2003.
This month, a class-action lawsuit was filed in New Jersey that accuses drug makers of promoting amiodarone for common heart ailments in an effort to boost profits. The suit contends that more than 1,000 people died, 100 had vision problems and thousands of others suffered severe medical complications.
When the FDA approved amiodarone for sale in the United States, it recognized that it was a dangerous drug and told doctors to be careful about its use.
Dr. Valentin Fuster, chairman of the American College of Cardiology's treatment guidelines committee for atrial fibrillation, said amiodarone shouldn't be the first drug a doctor tries when treating the disorder.
"You don't use amiodarone as a drug for this except after everything else fails," said Fuster, who also is director of the cardiovascular institute at Mount Sinai Medical Center in New York City. "Amiodarone carries a higher risk than other drugs."
Knight Ridder found that patients routinely were given little information about the drug's risks or alternative therapies. Over the years, the FDA has cited various manufacturers for playing down its risks and for promoting it as a first-line therapy.
In October 2003, Dr. Janet Woodcock, who at the time ran the FDA's drug division, said the agency would take the rare action of requiring the advisory in all amiodarone prescriptions.
Because of the dangers posed by the drug, Woodcock said the information would be written and distributed quickly, certainly by early 2004. "Obviously this drug is a very risky drug," she said then.
Woodcock, now the FDA's acting deputy commissioner for operations, didn't respond to requests for an interview over the past week.
The FDA first asked Wyeth to write the guide on Dec. 19, 2003, and the company gave the FDA a first draft Aug. 23. "That was in advance of what the FDA asked us and what we told them we would do," Wyeth spokesman Garland said. "We told them we would submit by November."
The FDA sent back its first comments on the guide Sept. 21, Garland said. Wyeth replied in October. The draft is now with the FDA, he said, adding that the process is happening quickly by drug regulation standards.
"Normally, the FDA can take up to six months to respond to an initial filing," Garland said.
In the lawsuit against Wyeth and several other makers of amiodarone, patients and their families accused the drug makers of pushing doctors to prescribe the drug for unapproved uses while concealing and playing down its risks.
"It's our belief there has been one long overpromotion of this drug," said David Harris, a Naples, Fla., attorney who filed the suit Nov. 10 in Atlantic County Superior Court in New Jersey. Officials at Wyeth, the lead defendant in the case, had no comment about the suit.
Karen Muccino is one of five plaintiffs. Her father, Dr. John Muccino, 69, had suffered from chronic atrial fibrillation since he was in his 40s, she said. When his heart was out of rhythm, it made him tired. He was put on various medications over the years with varying degrees of success. In October 2002, doctors put him on amiodarone, she said.
About a year later, he developed a dry cough. The cough worsened and by New Year's Day 2004 he was very ill with what he thought was a bad cold. Within days, he was hospitalized with what seemed to be pneumonia. A lung biopsy, however, found it was amiodarone lung damage, Karen Muccino said. Her father died after being taken off a respirator Feb. 20.
"There must be changes made and there must be some accuntabilitiy," said Muccino, a nurse by training and the vice president of a health care company. "There are so many medications that have labels on them saying 'Take with food or milk,' but you have a drug like this that has such slight warnings of an impending fatal situation and it isn't noted on the prescription bottle, which is totally ridiculous."
Users risk serious side effects:
What are amiodarone's risks?
The drug's FDA-approved prescribing label for doctors, which patients rarely see, warns that the drug comes with "substantial toxicity." About three-fourths of all patients taking a 400 mg dose experienced some side effects. Some can be fatal:
-- 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.
-- Liver injury is common. While usually mild, it can be fatal.
-- Worsening of the heart rhythm problem.
-- When given to pregnant women, the drug has seriously harmed the fetus.
Other side effects include thyroid problems and neurological disorders. Vision problems and blindness have been reported.
Should patients take amiodarone for atrial fibrillation?
The FDA hasn't approved amiodarone to treat atrial fibrillation. However, doctors are free to prescribe it "off label" after weighing the risks and benefits.
According to 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.
What can patients do?
-- Talk with your doctor. Ask why he or she chose rhythm control over rate control. For information about the AFFIRM study, go to 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.
-- Ask your pharmacist for a copy of the official prescribing label -- not just the single sheet that pharmacies often hand out with drugs. Or read the label online at www.cordarone.com.
