Millions still taking risky heart drug without warnings promised by FDA

[oldhat]

http://www.realcities.com/mld/krwashington/10256891.htm?template=contentModules/printstory.jsp

Millions still taking risky heart drug without warnings promised by FDA
By Alison Young
Knight Ridder Newspapers

WASHINGTON - 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 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.