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.

[cavanaghjam]

1. The FDA

is a wholly owned subsidiary of the pharma industry. The drug companies do the studies on their own drugs, the FDA simply rubber stamps them in most cases, an action understandable since the drug companies fund them (the FDA).

As an aside, I was surprised during the Martha Stewart/ImClone hoopla that no one asked the obvious question - What the hell is the FDA doing telling ImClone the results of the FDA judgment before they told the American public? Why should ImClone learn their drug had not met approval before anyone else? Our marvelous media sat on their thumbs in comatose stupor as usual.

[Bozita]

2. Mike Peters toon rips big pharma

[HysteryDiagnosis]

3. FDA = "Fatal Drugs Allowed" n/t

[Moderator]

4. Not LBN

Dated Nov. 23rd.