Yourlawyer.com (Amiodarone News)

FDA Launches Site to Warn Patients, Doctors of Drug Risks

Fri, 20 May 2005 00:00:00 -0700

The U.S. Food and Drug Administration has begun issuing alerts to patients and doctors on its Web site about emerging drug-safety concerns, including dangers posed by drugs prescribed for unapproved purposes.

The new site, called Drug Watch, marks a significant change in how the agency communicates risks to the public. In the past, the FDA has spent months or years privately weighing and debating risk information with drug companies until a final determination was made on the scientific significance of the danger.

After being bashed by Congress and consumers for its slow response to emerging information about heart risks posed by blockbuster pain medications such as Vioxx, the FDA now is beginning to make risk information available to the public much sooner.

"This is really a fundamental change," said Dr. Steven Galson, the acting director of the FDA's Center for Drug Evaluation and Research. "We do intend to give companies a heads up before posting something new about their drugs, but we're not going to discuss it with them. They're not going to review it."

The safety alerts posted so far on the site http://www.fda.gov/cder/drugSafety.htm are notable also because they emphasize risks posed by doctors prescribing drugs for purposes never approved by the FDA. It's a practice called "off-label prescribing" because it involves using drugs in ways and to treat conditions not covered by the safety and effectiveness determinations on their FDA-approved labels.

"That's a very important aspect of this," Galson said. "As you know, we don't regulate the practice of medicine. We have no way of preventing physicians from using drugs off label."

But Galson said the agency does have a responsibility to let people know about known risks of off-label uses. "This is very controversial, of course," he said.

Some off-label drug uses are beneficial and based on good science, others have little proof of effectiveness and still others have been proved worthless in studies.

Officials at the American Medical Association, which represents doctors, and the Pharmaceutical Research and Manufacturers of America, which represents drugmakers, declined to comment, saying they are evaluating the Drug Watch site and will submit formal comments to the FDA.

Ed Sagebiel, a spokesman for Indianapolis-based drugmaker Eli Lilly, said the company generally supports the FDA's new effort. The site includes alerts for Eli Lilly drugs Prozac, warning of suicide risks related to it and other antidepressants, and Zyprexa, warning of an increased risk of death when it and other atypical antipsychotics are prescribed off-label to treat dementia in elderly patients.

"We just want, from our standpoint, to properly balance warning people and patients of safety concerns without frightening them or inadvertently making them stop taking their medicines," Sagebiel said.

Galson said others in the drug industry have expressed similar concerns. "They're worried we may be over-warning and dissuading patients from using products that may do good," he said. "We expected we would get that sort of push-back."

Advocates for patients called the site an incremental move in the right direction, even though it requires patients to seek out the information on the Internet, rather than it being given to them when they pick up their medicines. The emphasis on early and off-label risk information is a departure for the FDA, they said.

"I don't think they had the political courage even a few years ago to take these kinds of steps," said Larry Sasich, a pharmacist with Public Citizen's Health Research Group, a consumer watchdog that publishes a searchable database of drug risks at www.worstpills.org.

Sasich said he thinks the FDA is realizing that the only way to change risky prescribing is for consumers to know more about the drugs they take. Changing the official labeling on drugs and sending letters to doctors about new risks hasn't worked, he said.

Sasich expressed concern that elderly patients who are the biggest consumers of prescription drugs won't have enough access to Drug Watch information that's available only on the Web.

Cynthia Pearson, the executive director of the National Women's Health Network in Washington, praised the direct communication of risks listed atop several drugs on the site.

"Our position always has been: Get people access to good information and they can make good decisions," Pearson said.

The Drug Watch site, still being developed, lists information on about 200 drugs. Most of them include routine prescribing information. Among those tagged with an "FDA Alert:"

Accutane, a drug for severe acne. "The FDA continues to assess reports of suicide or suicide attempts" associated with this drug. All patients "should be observed closely for symptoms of depression or suicidal thoughts," the alert warns.

Cytotec, also called misoprostol, a drug approved to prevent ulcers. The alert warns of risks in its off-label use in labor and delivery. "These uses are not approved by the FDA. No company has sent the FDA scientific proof that (Cytotec) is safe and effective for these uses. There can be serious side effects, including a torn uterus..." the alert warns.

Zyprexa, Risperdal and several other psychiatric drugs called atypical antipsychotics. The FDA warns that when prescribed off label as a treatment for dementia, older patients "had a higher chance for death than patients who did not take the medicine."

Amiodarone, marketed also as Cordarone and Pacerone, a popular heart drug approved only to treat a specific life-threatening rhythm disorder. It is widely prescribed off label for non-life-threatening atrial fibrillation. The alert warns of potentially fatal side effects including lung toxicity, liver injury and worsened heart rhythm problems.

Gabitril, a drug approved to treat seizures. The alert warns that it risks causing seizures when used off label. Gabitril's "safety and effectiveness have not been established for any other use," the alert notes, adding that the drug's maker, Cephalon, will be educating doctors "to discourage off-label use."

Sheryl Williams, a Cephalon spokeswoman, said through Drug Watch, the FDA appears to be trying to do a better job of communicating and addressing the increasing prevalence of off-label prescribing.

A Knight Ridder investigation published in 2003 found that patients are being injured and killed when doctors routinely prescribe medications in ways that the FDA has never approved as safe and effective. Off-label prescriptions for top-selling drugs accounted for nearly a quarter of their retail sales.

Williams said most of the prescriptions that doctors write for Gabitril are to treat psychiatric conditions - not epileptic seizures. Bipolar disorder is a particularly popular use, she said.

"The problem is there is no guidance for them to do so. We haven't done double-blind studies. We haven't even done single-blind studies," Williams said. "Our scientific team doesn't believe there is sufficient evidence that a drug like Gabitril would be effective in bipolar disorder."

While Gabitril is effective in reducing the frequency of seizures in people with epilepsy, she said, when used off label the drug has been associated with seizures in people without epilepsy.

After A Long Delay, FDA Approves Warnings For Heart Drug

Tue, 07 Dec 2004 00:00:00 -0800

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?"

Toxic Drug Lacks FDA Warning

Wed, 24 Nov 2004 00:00:00 -0800

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.

Each bottle of the drug, amiodarone sold under the brand names Cordarone and Pacerone as well several generics is supposed to include a new advisory that warns of its risks and 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.

The 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.

She said she's livid that the FDA didn't immediately issue the patient warnings last fall. "He would have been taken off the drug three months earlier and his life would have been saved," she said.

Sen. Charles Grassley, R-Iowa, chairman of the Senate Finance Committee, said yesterday 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," said Grassley. "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 from other side effects. Yet it's routinely prescribed for common heart rhythm problems despite the availability of 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 in a single year for atrial fibrillation and other heart conditions that amiodarone 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 ended July 31, 2003.

Earlier 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 have died, 100 have had vision problems and thousands of others have suffered severe medical complications.

FDA officials didn't respond to repeated requests for interviews about amiodarone and its efforts to protect consumers. An FDA spokeswoman instead referred questions to Wyeth, the drug maker assigned to write the advisory. Wyeth spokesman Chris Garland said the FDA could approve its advisory as early as next month.

What Are Amiodarone's Risks?

Wed, 24 Nov 2004 00:00:00 -0800

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.

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.

Injury to the liver. While usually mild, it too can be fatal.

Worsening of the heart rhythm problem.

When given to pregnant women, the drug has caused serious harm to the fetus. Other side effects include thyroid problems and neurological disorders. Vision problems and blindness also 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 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.

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

PRESCRIPTION DRUGS Heart Patients Taking Potentially Lethal Drug

Wed, 24 Nov 2004 00:00:00 -0800

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.

Each bottle of the drug, amiodarone, is supposed to include a new advisory that warns of its many risks and 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.

The delay comes as the FDA is being questioned about its slowness in protecting Americans from potentially 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, John, died Feb. 20 of lung damage caused by amiodarone. Despite his training as an obstetrician, Muccino said her father never realized his dry cough was a symptom of a potentially fatal side effect.

She said she is livid that the FDA did not immediately issue the patient warnings last fall. ''He would have been taken off the drug three months earlier and his life would have been saved,'' she 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,'' said Grassley, R-Iowa. ``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.''

NO FDA APPROVAL

Like most patients, John Muccino 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 from other side effects. Yet, it is routinely prescribed for common heart rhythm problems despite the availability of 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 two million prescriptions in a single year for atrial fibrillation and other heart conditions that amiodarone 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.

CLASS ACTION

Earlier 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 lawsuit contends that more than 1,000 people died, 100 had vision problems and thousands of others suffered severe medical complications.

FDA officials didn't respond to repeated requests for interviews about amiodarone and its efforts to protect consumers. An FDA spokeswoman instead referred questions to Wyeth, the drug maker assigned to write the advisory.

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 currently is sold by several generic manufacturers, as well as under another brand name, Pacerone.

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, the 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,'' he said.

Knight Ridder found that patients routinely got little information about its risks or alternative therapies. Over the years, the FDA has cited various manufacturers for downplaying the drug's 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.

Nor would anyone at the FDA respond to written questions about the appropriateness of allowing a drug maker to be in charge of writing warnings that may reduce its sales, or whether the delays are excessive.

Drug's Risk Notice Is Slow To Arrive

Sun, 25 Apr 2004 00:00:00 -0700

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 last 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 doctors or pharmacists never told them about the drug's life-threatening side effects or that the FDA hadn't approved the treatment as safe and effective.

A top FDA official said last October, in response to an investigation by Knight Ridder newspapers, that the agency would take the rare action of requiring that 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 the drug manufacturer would say when it would be distributed.

"We're in the midst of that project," said Doug Petkus, a spokesman for Wyeth, which makes Cordarone, a brand-name version of the 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 gain FDA approval. He wouldn't say when the guide will be done.

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."

In the past, other companies have been able to distribute medication guides to consumers in less than six months.

Amiodarone can be highly toxic to patients and causes a wide range of serious side effects. In some studies, as many as 17 percent of patients have experienced lung damage with 10 percent dying from it. Others have suffered liver problems and blindness.

Rarely do doctors inform patients of off-label prescribing, which means using a drug in ways the FDA never approved. While legal, such use can upset the balance between risk and benefit that's crucial to get a drug approved and on the market.

Because of the side effects, the FDA approved the drug only to treat life-threatening heart conditions called ventricular tachycardia and ventricular fibrillation, and only 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 it sales, according to a Knight Ridder analysis of drug industry data published last fall.

The FDA wouldn't say if other makers are drafting a guide. Officials at Upsher-Smith Laboratories in Maple Grove, Minn., which sells Pacerone, had no comment.

Heart Drug Guide Indicating Risks Misses Deadline

Fri, 23 Apr 2004 00:00:00 -0700

Amiodarone Toxic Epidermal Necrolysis Side Effects Lawyer

Fri, 23 Apr 2004 00:00:00 -0700

Injured by Amiodarone?

The Food & Drug Administration (FDA) approved Amiodarone, manufactured by Wyeth, on January 5, 1999. Amiodarone is prescribed too treat heart rhythm disorders such as atrial fibrillation and atrial flutte. Doctors are prescribing this drug for off-label use without warning their patients about the drug's life-threatening side effects or that the FDA had not approved their treatment as safe and effective.

Amiodarone (brand names: Cordarone and Pacerone) has been linked to severe side effects such as blindness, lung damage, and Toxic Epidermal Necrolysis (TEN). Many patients some left blind or with severely damaged lungs say doctors or pharmacists never told them about the drug's life-threatening side effects or that the FDA hadn't approved the treatment as safe and effective.

Toxic Epidermal Necrolysis (TEN) is a rare condition that causes large portions of the epidermis, the skin's outermost layer, to disengage from the layers of skin below. The main cause of Toxic Epidermal Necrolysis (TEN) is a severe drug reaction.

In response to an investigation by Knight Ridder, that the FDA said it would require all Amiodarone prescriptions be dispensed with a special patient medication guide detailing the drug's dangers and what conditions it is approved to treat. Patients were supposed to begin receiving the FDA-approved warning guides by early 2004, however six months later they are still under development and not being disseminated.

Amiodarone can be highly toxic to patients and causes a wide range of serious side effects. In some studies, as many as 17% of patients have experienced lung damage with 10% dying from it. Rarely do doctors inform patients of off-label prescribing, which means using a drug in ways the FDA never approved. While legal, such use can upset the balance between risk and benefit that's crucial to get a drug approved and on the market.

In 2004 doctors wrote nearly 2.3 million prescriptions for Amiodarone to treat atrial fibrillation and other unapproved conditions accounting for 82 percent of it sales, according to a Knight Ridder analysis of drug industry data published last fall.

Off-label prescribing involves a doctor using a drug in ways the FDA never approved and therefore aren't listed on its label. While going off-label is legal, such use can upset the balance between risk and benefit that is crucial to get a drug approved and on the market.

If you or a loved one took Amiodarone and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.