FDA Warns Of Potential Risk Of Liver Failure Associated With Use Of IGIV
ProductsWESTPORT, Oct 01 (Reuters Health) - The Food and Drug Administration
has sent a letter to physicians alerting them about safety precautions that
should be taken when administering immune globulin intravenous (IGIV) products
in order to reduce the "potential" risk of acute renal failure.
According to the FDA, the agency has received 114 adverse event reports
worldwide, 83 of which are from the US, of renal dysfunction or acute renal
failure associated with administration of IGIV products. Since the IGIV
products were first introduced in 1981, there have been reports of death due to
acute renal failure in 17 patients worldwide, although many of the patients had
"...serious underlying conditions," according to the agency.
The FDA said that preliminary evidence suggests that IGIV products that
contain sucrose might pose a greater risk for acute renal
failure. Approximately 88% of the US cases were associated with
sucrose-containing products.
Among the cases reported in the US, 69% were associated with Novartis
Pharmaceuticals' Sandoglobulin and American Red Cross' Panglobulin, both of
which contain sucrose. Twenty-two percent of the cases were associated with
Centeon's Gammar-P I.V. and Gammar I.V., both of which contain sucrose.
Four of the cases were reported among users of Bayer's Gamimune, which does not
contain sucrose, and three of the cases were reported among users of American
Red Cross' Polygam and Baxter's Gammagard, neither of which contain sucrose.
There were no reported cases of liver failure or dysfunction among users of
Baxter's Iveegam or Alpha Therapeutic's Venoglobulin.
The FDA now recommends that physicians ensure that patients are not volume
depleted prior to an infusion of IGIV and that physicians take particular caution
with patients who are at increased risk of liver failure, including patients
with pre-existing renal insufficiency, diabetes, sepsis, paraproteinemia,
concomitant nephrotoxic drug use, and patients older than 65 of age.
The FDA also said that physicians should not exceed the recommended dose for
these products, should periodically monitor renal function and urine output of
patients, and should instruct patients to report symptoms of decreased urine
output, sudden weight gain, fluid retention, and/or shortness of breath.
http://www.plateauconsulting.com/toxicdiscoverynetwork/articles.htm
What is routinely given intravenously during surgery? Glucose water! When
Ringer's Lactate (which has no sugar) is used instead, the incidence of post
operative infection is reduced by two thirds. The only reason I can think of
for this kind of persistent ignorance is that there is no money in changing the
thinking of operative routine. There is a lot more money in treating the
infections that are created by the Allopathic Monopoly.
http://www.bcn.net/~stoll/sugarimm.html
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