US probes Chinese maker of blood thinner

[Guest guest]

Why does the USA continue to accept poisonous products from China? The FDA

seems to have a dismal track record so who is protecting American consumers from

all the harm being done? Four people had to die before this was looked into.

Betsy

 

WASHINGTON - U.S. health officials said Wednesday they have not inspected a

Chinese factory that may be a source of problems with a blood thinner linked to

allergic reactions and four deaths, but plan an inspection as soon as possible.

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The Baxter International blood thinner has been linked to hundreds of reports

of allergic reactions and the four deaths. The Food and Drug Administration is

investigating.

" While no FDA inspection of the facility has been conducted to date,

preparations are being made to perform an inspection as soon as possible, " the

FDA said in a statement. " We have already requested expedited access to the

facility, facilitated through a recently signed agreement with the Chinese State

Food and Drug Administration. "

The FDA has also requested the facility's inspection data and other reports.

Baxter buys the active ingredient for the drug heparin from a supplier that

manufactures it both at the Chinese factory and a facility in the U.S., Baxter

spokeswoman Erin Gardiner said.

Baxter inspected both facilities last year and found no quality issues,

Gardiner said. However, the company plans to re-inspect the facilities " very

soon " as part of its own investigation, she said.

FDA spokeswoman Karen Riley emphasized in an e-mail response to an Associated

Press query that the agency has " just begun our investigation, and we don't know

the cause of these allergic reactions. It could be any number of things. The

active ingredient is only one of the potential suspects we must look at. "

Earlier this week, the FDA told doctors to switch from using Baxter's heparin,

citing 350 reports of side effects so far this year. Four people died while

taking the drug, although the agency said it wasn't clear if the heparin was to

blame. In all of 2007, the FDA received 100 reports of problems with the drug.

Last month, Baxter had recalled nine lots of the injectable drug after

learning of allergic reactions among dialysis patients, problems ranging from

dizziness and fainting to a racing heartbeat. This week, Baxter said it would

stop manufacturing multiple-dose vials while it and FDA attempted to locate the

source of the problems.

Baxter accounts for about half the U.S. supply of heparin.