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Toxic Drug Lacks FDA Warning


Nov 24, 2004 | Knight Ridder

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.

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