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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