Several studies have been carried out to evaluate the safety of Avemar in doses used for treatment of cancer and autoimmune diseases.
Boros et al discussed some of the studies in animals and humans that provide an indication of its safety; studies in these species to date suggest few adverse effects of Avemar. Acute and subacute toxicology tests carried out in a Good Laboratory Practice (GLP) setting revealed minimal side effects. Toxicity studies in the rat and mouse demonstrated an acute oral LD50 of Avemar in male and female mice and rats of greater than 2,000 mg/kg. The no-observable adverse effect level, which is the greatest concentration or amount of Avemar that causes no detectable adverse alteration, was 2,000 mg/kg/day in rats, and in a subchronic study with mice and rats was found to be 3,000 mg/kg/day. There is a wide therapeutic window for Avemar. Doses toxic to normal cells are more than 50 times higher than the dosage recommended for therapy, which suggests that a wide range of therapeutic dosages can be tested before the product becomes toxic.
The US Food and Drug Administration recently granted Avemar a status of Generally Recognized As Safe (GRAS), which allows it to be used in foods, drinks, and dietary supplements. Significant side effects have not been reported, but mild and transient diarrhea, nausea, flatulence, soft stool, constipation, dizziness, and increase in body weight can accompany the consumption of Avemar. Hematologic evaluations of hospitalized cancer patients in Hungary found that the white blood cell count, lymphocyte count, neutrophil granulocyte count, monocyte count, eosinophil granulocyte count, hemoglobin level, red blood cell count, erythrocyte sedimentation rate, hematocrit, platelet count, and prothrombin level were normal after 1-5 years of Avemar treatment.