[ SHOWGSD-L ] BLOOD THINNER - HUMAN
- From: MORGAN LEWIS <shadowland22000@xxxxxxxxx>
- To: gsd911@xxxxxxxxxxxxxxx, gsd showlist <showgsd-l@xxxxxxxxxxxxx>, whiteshepherdgenetics@xxxxxxxxxxxxxxx
- Date: Thu, 14 Feb 2008 07:19:49 -0800 (PST)
nOT SURE IF ANY OF OUR CANINES EVER HAVE TO USE BLOOD THINNERS, BUT LOTS OF
HUMAN'S DO. pLEASE EXPLAIN TO ME WHY WITH ALL THE QUALITY CONTROL PROBLEMS
CHINA HAS, WOULD WE EVER BUY DRUGS
SO POTENT FROM A COUNTRY WHO OBVIOUSLY DOES NOT EITHER KNOW OR CARE ABOUT
HUMAN LIFE. MORGAN
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.
Morgan and His Angels
Precious, OFA
Princess, CGC, TDI, GSDCA Health Award
"RAW" fed, No Vaccinations
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