Hazard assessment of germanium supplements.
Germanium-containing dietary supplements became popular in the 1970s in Japan and later in other countries, as elixirs for certain diseases (e.g., cancer and AIDS). Germanium is not an essential element. Its acute toxicity is low. However, at least 31 reported human cases linked prolonged intake of germanium products with renal failure and even death. Signs of kidney dysfunction, kidney tubular degeneration, and germanium accumulation were observed. Other adverse effects were anemia, muscle weakness, and peripheral neuropathy. Recovery of renal function is slow and incomplete even long after germanium intake was stopped. The total dose of ingested germanium (as dioxide, carboxyethyl germanium sesquioxide, germanium-lactate-citrate, or unspecified forms) varied from 15 to over 300 g; the exposure duration varied from 2 to 36 months. In laboratory animals, elevated germanium in tissues and impaired kidney and liver function were observed in a life-time drinking water (5 ppm germanium) study. Other toxicities associated with ingested germanium products in human cases were also demonstrated in animal studies with germanium dioxide and sometimes other germanium compounds. Based on the evidence of persistent renal toxicity associated with germanium dioxide, the lack of conclusive findings of differential nephrotoxicity of organic germanium compounds, and the possibility of contamination of the organic germanium products with inorganic germanium, it is clear that germanium products present a potential human health hazard.
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Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204, USA.
Bolger
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D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000740:Anemia / Q000139:chemically induced; D000818:Animals; D016587:Antimutagenic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000633:toxicity; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000633:toxicity; D002648:Child; D002675:Child, Preschool; D005260:Female; D005527:Food, Fortified; D005857:Germanium / Q000009:adverse effects* / Q000494:pharmacology / Q000633:toxicity; D006801:Humans; D007668:Kidney / Q000187:drug effects*; D007928:Lethal Dose 50; D008099:Liver / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D018908:Muscle Weakness / Q000139:chemically induced; D009474:Neurons / Q000187:drug effects; D009942:Organometallic Compounds / Q000009:adverse effects / Q000494:pharmacology / Q000633:toxicity; D011422:Propionates; D051437:Renal Insufficiency / Q000139:chemically induced; D018570:Risk Assessment
D016587:Antimutagenic Agents; D000970:Antineoplastic Agents; D009942:Organometallic Compounds; D011422:Propionates; D005857:Germanium; C066750:propagermanium; C040516:germanium oxide