FDA Cites Deaths Associated with Imported Organic Germanium Products
In 1993, the FDA published an article entitled "Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace.” Under a section entitled "Illnesses and Injuries Associated With the Use of Selected Dietary Supplements". Germanium is targeted in a “list of selected dietary supplements associated with serious safety problems”. This was on account of contamination problems encountered with Aisian sources of organic germanium that caused acute renal failure and even some deaths.
Germanium is a nonessential element. Recently, germanium has been marketed in the form of inorganic germanium salts and novel organogermanium compounds, as a "dietary supplement." These products are promoted for their claimed immunomodulatory effects or as "health-promoting" elixirs. Germanium supplements, when used chronically, have caused nephrotoxicity (kidney injury) and death. Since 1982, there have been 20 reported cases of acute renal failure, including two deaths, attributed to oral intakes of germanium elixirs. In surviving patients, kidney function has improved after discontinuation of germanium, but none of the patients have recovered normal kidney function.
One particular organogermanium compound, an azaspiran organogermanium, has been studied for its potential use as an anticancer drug. Forty percent of the patients in this study experienced transient neurotoxicity (nerve damage), and two patients developed pulmonary toxicity. Because of these side effects, medically supervised administration of this drug with monitoring for toxicity has been recommended for those using germanium chronically. http://www.cfsan.fda.gov/~dms/ds-ill.html.
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