FDA Says It Approved The Wrong Drug Plant, Causing Spike In Serious Problems, 4 Die

[babylonsister]

FDA Says It Approved The Wrong Drug Plant
Heparin Probe Sends Inspectors to China


The Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected by the Food and Drug Administration because the agency confused its name with another just like it, agency officials said yesterday.

The FDA said that a team of inspectors is headed now to China to inspect the plant as part of an effort to determine what may have caused a sudden spike in serious problems with the drug, which has been on the market since the 1930s.

More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007, including a dangerous lowering of blood pressure, breathing difficulties and vomiting. Four patients who took the drug died. One of its two manufacturers, Baxter International, stopped selling its multiple-dose vials of heparin earlier this month, and yesterday the FDA advised doctors to prescribe alternatives.

Millions of people each year are given the drug during dialysis or to prevent complications from surgery, but the FDA has never checked the Chinese plant where the active ingredient is made. The agency and Baxter are investigating whether anomalies in the ingredients from China could have caused the dangerous reactions in some patients.

Joseph Famulare, deputy director for compliance at the FDA's center for drug evaluation and research, said yesterday in a conference call with reporters that when the company that makes the active ingredient for heparin applied for FDA approval, the FDA thought the application had come from a different company with a similar name that had already been inspected.

"To date this is an isolated situation, but the wrong firm was put into the database," he said. Famulare declined to name the Chinese company approved by mistake.

more...

http://www.washingtonpost.com/wp-dyn/content/article/2008/02/18/AR2008021802315.html?hpid=topnews

[ClassWarrior]

1. So why are we supposed to believe that "conservative" and "governance" aren't oxymorons?

NGU.

[Romulox]

2. "Free trade" with China isn't a Republican issue, unfortunately...

You can thank the big dog for this too.

[babylonsister]

4. Hmmm. Remind me again why he was considered so great? nt

[leftchick]

5. he fooled a lot of folks

still does apparently.

[lumberjack_jeff]

3. It is a clever move to name all of your factories the same thing.

Then give directions to the clean, tidy, well equipped one.

[global1]

6. Are You Kidding Me - The FDA Actually Admitted They Made A Mistake?.......

that's hard to believe from an agency that can never be pinned down on anything!!!!!!!