How the FDA let down America with a watered-down warning about amiodarone

This is a draft news release. Comments are welcome until it is finalized and distributed.

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 in 2003.

In late 2004, the FDA required the makers of Cordarone and Pacerone, the then current brand names for amiodarone, to update their labels to include a black box with three important warnings:

1. This is a drug of last resort;
2. The drug results in 10-17 percent toxicity; and,
3. The drug results in 10 percent fatality.

Despite the fact that amiodarone kills one of 10 people who take it, the black box warnings stayed in effect for only a brief time before being watered down with less truthful labels dominated by legalese.

According to a story in the Nov. 24, 2004, Miami Herald, each dose or prescription of the drug amiodarone was supposed to include the new advisory that warned of its many risks and symptoms of fatal side effects and explained how the medication is supposed to be used. But the advisory, first discussed in October 2003, remained in draft form into late 2004, bouncing back and forth between the FDA and Wyeth,  the drug maker assigned by the FDA to write it.

The delay came in the midst of the FDA being questioned about its slowness in protecting Americans from potentially deadly drugs.

''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, 2004, 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 of the drug.

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.

She said she was livid that the FDA did not immediately issue the patient warnings in the autumn of 2003. ''He would have been taken off the drug three months earlier and his life would have been saved,'' she said.

''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,'' Sen. Charles Grassley (R-Iowa) said at the time.

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 on 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.

The FDA initially approved amiodarone only for more severe disorders, and then only as a treatment of last resort. The approval was given without the drug undergoing clinical trials.

Patients taking amiodarone have for years right up to the present died from lung, thyroid and liver damage, gone blind or suffered from other side effects. The most common side effect is fatal lung damage. Yet, it is routinely prescribed for common heart rhythm problems despite the availability of safer alternatives.

According to 2004 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 in 2003 found that those prescriptions represented 82 percent of all the amiodarone dispensed from retail pharmacies during the 12-month period ending July 31, 2003.

In 2004, a class-action lawsuit was filed in New Jersey that accused drug makers of promoting branded versions of amiodarone for common heart ailments in an effort to boost their profits regardless of consequences for victims. The lawsuit contended that more than 1,000 people died, 100 had vision problems and thousands of others suffered severe medical complications from the branded versions of amiodarone.

U.S. drug companies initially marketed the drug under the trade names Cordarone and Pacerone. The drug rights for the Pacerone brand of amiodarone were initially held by Upsher-Smith Laboratories, and for the Cordarone brand by Wyeth-Ayerst Laboratories.

When a law firm tried to sue Wyeth in a class action, Wyeth and Upsher abandoned their brands, and the drugs went generic. The lawsuit was withdrawn. The generic drug amiodarone is now manufactured mainly in India and imported to the U.S.

By making the drug generic, the drug companies that were marketing amiodarone as Cordarone and Pacerone avoided class action litigation. The U.S. Supreme Court has ruled that the only causes of action a patient may take against a generic drug manufacturer is for a failure to warn if the generic drug does not copy the FDA-approved label exactly.

The FDA, meanwhile, had in 2003 asked Wyeth, the drug maker, to write a warning advisory for amiodarone prescriptions. Wyeth was given the job of writing the informational guide because it was the first company to sell the drug.

Wyeth spokesman Chris Garland said in 2004 that the FDA could approve the Wyeth advisory as early as December 2004.

In 2004, no one at the FDA would respond to written questions about the appropriateness of allowing a drug maker to be in charge of writing warnings that could reduce the drug’s sales, or whether the delays were excessive.

Dr. Valentin Fuster, the chairman of the American College of Cardiology's treatment guidelines committee for atrial fibrillation, said in 2004 that amiodarone shouldn't be the first drug a doctor tries when treating fibrillation. ''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 2011, a Texas lawyer, Justin Williams, filed an action in which his firm first went to the FDA website looking for labeling information.  The FDA requirements for complete labeling by manufacturers were not available at the FDA site. What his firm eventually found was that manufacturers of generic amiodarone had updated their labels in 1998, 2000, and 2002, with no other updates until 2010.

Williams concluded from labels he had obtained from various victims of amiodarone poisoning and their family members that the targets in the lawsuit had failed to update their labels with appropriate warnings, so at they could be sued.

Williams filed suit and says he immediately became involved in one legal battle after another. The offshore companies making and marketing amiodarone hired one of the most aggressive, expensive and “win at all costs no matter what justice is” law firms in America.

The manufacturers produced labels from the years after the FDA required modifications after the initial black box warning. They produced labels Williams did not have from prior years that had the required warnings.

The unfortunate truth is most cardiologists and electrophysiologists who prescribe amiodarone don’t believe the watered-down warnings that come with amiodarone. They think the warnings are "just stuff the lawyers require." Many do not tell patients about the warnings and dangers because they have been bought off or brainwashed by drug companies to think the side effects will never happen to their patients.

Representative Henry  Waxman (D-Calif.) is currently trying to get a law passed to give the same rights to sue the makers of generics as victims have to sue the makers of brand name drugs.