Germanium 150 mg [Discontinued] by Douglas Laboratories

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Cancer. Researchers have been interested in spirogermanium, an organometallic form of germanium, as an alternative or palliative treatment for various kinds of cancer including breast cancer, colon cancer, prostate cancer, ovarian cancer, head and neck cancer, and lung cancer (10035,10037,10038,10039,10049,10050). However, response rates in phase I and II trials have generally been low, with only a few reports of partial responses or stable disease (10038,10039,10049,10050). There is preliminary clinical data suggesting that taking propagermanium, another organometallic form of germanium, orally 10-40 mg daily for 1-7 months, might be beneficial for people with multiple myeloma. In a group of 10 patients, 2 had complete remissions, 2 had partial remissions, and 4 had stable disease (51746).
• Hepatitis B. Preliminary clinical research shows that taking a specific product (Serocion, Yamanouchi) containing propagermanium, an organometallic form of germanium, orally 30 mg daily for 16 weeks, helps to clear hepatitis B e-antigen (HBeAg) from the blood, suggesting a reduction in the amount of active virus. The response is sustained for at least 48 weeks (51743). More evidence is needed to rate germanium for these uses.

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LIKELY SAFE ...when germanium is ingested in amounts typically found in food 4-3.4 mg daily) (557,51753).

POSSIBLY UNSAFE ...when products containing organometallic forms of germanium are used orally or intravenously. There is no known biological requirement for germanium in humans, and intake of any form can increase germanium levels in the body well above normal. Renal failure, multi-organ dysfunction, pulmonary toxicity, and neurotoxicity have all been reported in patients using organometallic forms of germanium (10043,10044).

LIKELY UNSAFE ...when inorganic germanium compounds, such as germanium oxide are taken orally; avoid using. There have been more than 30 reports of renal tubular cell damage with renal failure, hepatic steatosis, lactic acidosis, myopathy, peripheral neuropathy, cerebellar ataxia, and degeneration of the dorsal column of the spinal cord. These toxic effects can be irreversible and have led to several deaths. Daily doses of elemental germanium associated with toxicity have ranged from 30-961 mg, with total cumulative doses of 15-328 grams consumed over 1 to 42 months (557,10040,10041,10042,10044,10052,10072,10073,10074,51747)(51748,51749,51751,51752,51753) (51755,51762,104529).

PREGNANCY AND LACTATION: LIKELY UNSAFE
when used orally due to reported toxicity (557,10051); avoid using.

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General ...Orally, germanium is well tolerated in amounts typically found in the diet, 0. 4-3.4 mg daily (557,51753). However, there have been more than 30 reports of renal tubular cell damage with renal failure, hepatic steatosis, lactic acidosis, myopathy, peripheral neuropathy, cerebellar ataxia, and degeneration of the dorsal column of the spinal cord, in some cases leading to death, when organic or inorganic germanium compounds are taken orally (557,10040,10041,10042,10043,10044,10052,10072,10073,10074)(51747,51748,51749,51751,51752,51753)(51755,51762,104529).

Dermatologic ...Orally, one case of skin rash has been reported for a 38-year-old woman who had taken 600 mg of a germanium preparation as an elixir daily for 18 months. The preparation was found to be mainly germanium dioxide with some organic compound present (51762).

Hematologic ...Orally, germanium can cause anemia (557).

Hepatic ...Orally, germanium has caused hepatic steatosis (557,10042,10073).

Musculoskeletal ...Orally, muscle weakness or myopathy are among the most common symptoms of germanium toxicity (557,10040). In one case report, a 38-year-old woman presented with myopathy after taking 600 mg of a germanium preparation daily for 18 months as an elixir. The preparation was found to be mainly germanium dioxide with some organic compound present (51762).

Neurologic/CNS ...Orally, germanium has caused peripheral neuropathy (557). Intravenously, transient lethargy, dizziness, visual blurring, and ataxia were the main adverse effects to the organic compound, spirogermanium. Less common adverse effects were persistent loss of taste and weakness, and a seizure. At doses above 250 mg/m2 daily tremors and mental confusion are more severe (10038,10049,51770).

Psychiatric ...Orally, depression occurred in two patients receiving an organometallic preparation of germanium called propagermanium 30 mg daily (51746).

Pulmonary/Respiratory ...Intravenously, two cases of pulmonary toxicity have been reported for patients taking an organometallic preparation of germanium called spirogermanium (10044).

Renal ...Orally, germanium can cause renal tubular degeneration and renal failure (557,10041,10042,10044,10073,10074,51740,51751,51753,51762). In one case report, a 38-year-old woman presented with renal failure eventually leading to death after taking 600 mg of a germanium preparation daily for 18 months as an elixir. The preparation was found to be mainly germanium dioxide with some organic compound present (51762). In another case, severe lactic acidosis causing death was thought to be related to renal tubular degeneration leading to renal failure (10073).

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