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PubMed1977

Fatal hepatic coma complicating oxymetholone therapy in multiple myeloma.

Two patients with multiple myeloma died in acute liver failure. Both had been treated with the anabolic steroid oxymetholone and both subsequently developed severe cholestatic hepatitis. In one the histological lesion progressed despite cessation of oxymetholone therapy. Myeloma infiltration of the liver and peliosis hepatis were not seen. As a fatal outcome from cholestatic hepatitis due to oxymetholone is rare it is possible that an unknown potentiating factor is present in multiple myeloma that can lead to a fatal outcome. If oxymetholone therapy is to be used in such patients then close clinical and laboratory assessment of liver function should be carried out in an attempt to prevent this unusual and fatal complication.

Cholestasis↗
PubMed1976

Oxymetholone effect of acute myeloblastic leukemia cells in vitro.

The possibility that oxymetholone might induce or enhance leukemia after androgen therapy for aplastic anemia prompted us to study the direct action of oxymetholone on the DNA synthesis of AML cells in vitro. The peripheral blasts of 10 patients, 8 with AML and 2 with CML in blast crisis have been studied. The DNA synthesis of the leukemic cells with and without oxymetholone was measured by the 3H-methyl-thymidine incorporation determined by liquid scintillation. The results have been shown a wide variation of DNA synthesis from patient to patient with a range from 2,000 to 40,000 cpm but no significant difference between test and control cultures. We may conclude that oxymetholone does not increase directly the proliferation capacity of the peripheral AML cells cultured in vitro.

Adolescent↗
PubMed1980

Fanconi anemia. Oxymetholone hepatic tumors, and chromosome aberrations associated with leukemic transition.

Jaundice and hepatomegaly developed in a boy with Fanconi anemia after he had undergone treatment with oxymetholone for nine years. A liver scan showed patchy uptake consistent with the presence of space-occupying lesions. After oxymetholone treatment was stopped, the jaundice resolved, the liver size decreased, and the filling defects were no longer detectable on the liver scan. A year later, 5% of his white blood cells showed a consistent chromosomal abnormality. His leukocyte count increased and 85% of these cells showed the same chromosomal abnormality. The rapid replication of this abnormal clone suggests that it was leukemic. The significance of oxymetholone therapy and the occurrence of hepatic tumors and leukemia is discussed.

Anemia, Aplastic↗
PubMed1982

A case of leukemic reticuloendotheliosis responding to oxymetholone.

A 63-year-old man presented with fever, easy bruisability, splenomegaly and pancytopenia. Bone marrow aspiration was unsuccessful, and marrow biopsy revealed crowding by sheets of mononuclear cells; a diagnosis of leukemic reticuloendotheliosis (LRE) was made and the patient underwent splenectomy. There was no hematologic improvement, and the patient continued to have a significant requirement for erythrocytes and platelet transfusions. Within two months of beginning oxymetholone therapy (50 mg orally three times a day) the patient's platelet count had normalized, followed by improved erythrocyte and leukocyte counts. When the drug was discontinued, the peripheral blood counts deteriorated drastically; he again demonstrated hematologic improvement when oxymetholone therapy was reinstated. We feel that by demonstrating a hematologic response to oxymetholone, relapse when it was withdrawn, and another remission upon readministration, that we have provided stronger evidence than previously reported for the efficacy of this drug in LRE.

Adult↗
PubMed1978

Oxymetholone treatment in myelofibrosis.

In order to study the effect of oxymetholone therapy in advanced myelofibrosis, 11 patients (4 females, 7 males) were given, 3--5 mg per kg body weight, long-term oxymetholone treatment in a prospective multicenter study. Five cases had previously had a diagnosis of polycythemia vera. All patients had anemia initially, 4 leukocytopenia and 10 thrombocytopenia in addition. Hepato-splenomegaly was present in all cases but in varying degree. Five patients required regular blood transfusions before treatment. In 9 of the 15 courses given, there was normalization of the peripheral blood or substantial improvement (better than 3 g hemoglobin/dl or 50 X 10(9) platelets/1) after androgens. Significant effects were noted both on hemoglobin values and platelet counts. The need for blood transfusions ceased completely in all 5 cases. When oxymetholone treatment was reduced or interrupted 4 patients relapsed; 2 of them responded to a renewed course. The red cell counts returned to previous polycythemic values in one patient and another died from acute leukemia. The results of this study suggest that androgens might be of value in advanced cases of myelofibrosis with transfusion-requiring anemia or severe thrombocytopenia.

Aged↗
PubMed1979

Clinical and biochemical effects of impeded androgen (oxymetholone) therapy of hereditary angioedema.

Daily therapy and alternate-day therapy with the attenuated androgen oxymetholone were compared in patients with hereditary angioedema (HAE). Fifteen of 16 patients who experienced at least monthly attacks of HAE without treatment were asymptomatic on administration of 5 mg oxymetholene daily. When 13 of the patients who had been maintained asymptomatically on 5 mg oxymetholone daily were advanced to a treatment schedule of 5 mg every other day, seven attacks occurred during a cummulative 50 mo of therapy. The adverse effects that occurred with daily oxymetholone therapy largely subsided when the patients received alternate-day therapy, while a significant mean rise in C4 protein and function occurred only on daily therapy. Statistically significant mean increases in serum levels of C1INH occurred with daily therapy and were maintained with alternate-day therapy. Clinical benefit can be obtained with a treatment program that does not produce a statistically significant rise in C4 protein or function and does not raise C1INH to the lower limit of normal. The finding that alternate-day therapy diminished the side effects of the drug while affording a substantial reduction in the incidence and severity of attacks indicates the feasibility of this therapeutic approach.

Adult↗
PubMed2005

Intracerebroventricular self-administration of commonly abused anabolic-androgenic steroids in male hamsters (Mesocricetus auratus): nandrolone, drostanolone, oxymetholone, and stanozolol.

Previous studies by the authors have shown voluntary intracerebroventricular (icv) testosterone self-administration in hamsters (Mesocricetus auratus). Here, the authors compared icv self-administration of 4 anabolic steroids (drostanolone, nandrolone, oxymetholone, and stanozolol) at 0.1, 1.0, and 2.0 microg/microl, each for 8 days. Males (n=8/group) showed the highest levels of operant behavior for injectable steroids (drostanolone, nandrolone) compared with orally active androgens (oxymetholone, stanozolol). For nandrolone, responses on the active and inactive nose-pokes averaged 22.3 +/- 4.6/4 hr and 10.7 +/- 2.0/4 hr, respectively. Responding for drostanolone was similar. Males self-administering oxymetholone or stanozolol did not prefer the active nose-poke. These data demonstrate that injectable androgens are more reinforcing than oral steroids.

Analysis of Variance↗
PubMed2003

Effect of oxymetholone on SCE frequency in human lymphocyte chromosomes in vitro.

Genotoxicity evaluation of a commonly used synthetic androgen, Oxymetholone, was carried out in human peripheral blood lymphocytes in vitro. Sister chromatid exchange (SCE) was used as genetic end point. The concentrations of the drug were determined after observing its effects on the mitotic index. A wide range of concentrations, i.e., 25, 50, and 100 micro g/ml of the drug, were used to determine the genotoxic effects in the absence as well as in the presence of rat liver microsomal activation system (S9 mix). The drug did not induce any significant increase in the SCE frequency at any of the concentrations either in the presence or in the absence of S9 mix. The maximum value of SCE was observed in the absence of S9 mix at 100 microg/ml concentration (i.e., 1.38+/-0.080/cell), which was not significant statistically. Moreover, the drug was not effective in increasing the SCE frequency even in the presence of S9 mix. The maximum value of SCE (i.e., 1.78+/-0.103/cell) was observed at 50 microg/ml of concentration in the presence of S9 mix. A dose relationship was also not observed. It was concluded that Oxymetholone does not affect the genetic material in human lymphocytes at a wide range of concentrations in the SCE assay.

Anabolic Agents↗
PubMed1998

Stanozolol, oxymetholone, and testosterone cypionate effects on the rat estrous cycle.

Anabolic-androgenic steroid (AAS) effects on the estrous cycle of adult Long-Evans rats were examined in four different experiments. Sexual receptivity, vaginal cytology, and body weight were monitored throughout two-week baseline, AAS treatment, and recovery periods. In Experiments 1-3, rats were administered stanozolol, oxymetholone, or testosterone cypionate within dose ranges selected to mimic the human abuse levels of each compound. In these studies, the highest doses of stanozolol (5 mg/kg), oxymetholone (12 mg/kg), or testosterone cypionate (7.5 mg/kg) disrupted the cyclical display of sexual receptivity and vaginal estrus. To compare effects on estrous cyclicity across AAS compounds, rats in Experiment 4 received a single dose (7.5 mg/kg) of each compound for 2 weeks. At the 7.5 mg/kg dose, all AAS compounds interfered with the cyclical display of vaginal estrus, although effects on sexual receptivity were not uniform. No striking AAS effects on body weight were seen in any experiment. The short-term administration of AAS compounds at high doses disrupts female neuroendocrine function in rats.

Anabolic Agents↗
PubMed2002

Validation of the determination of oxymetholone in human plasma analysis using gas chromatography-mass spectrometry. Application to pharmacokinetic studies.

A simple and rapid procedure for extraction of oxymetholone in human plasma using gas chromatography coupled with quadrupole mass spectrometric was evaluated. The method involves analyte extraction with tert.-butylmethylether after alkalinization of the plasma and derivatization with MSTFA-NH(4)I-2-mercaptoethanol before the high resolution gas chromatographic-mass spectrometry separation. Methyltestosterone was used as internal standard. The calibration curves were linear, with typical r(2) values >0.995 and F(table)>F(calculated) (alpha=0.05). Recovery from plasma proved to be more than 70%. The method was accurate and reproducible, and was successfully applied to determine the pharmacokinetic parameters of oxymetholone for healthy volunteers after oral administration of 50 mg of the compound. The (C(max)) and (T(max)) were 18.8 +/- 0.4 ng/ml and 210 +/- 42.4 min, respectively.

Adult↗
PubMed1978

Effect of sodium fluoride, inorganic phosphate, and oxymetholone therapies in osteoporosis: a six-year progress report.

Elderly osteoporotic males treated with sodium fluoride or inorganic phosphate for 4 years plus 2 years of follow-up observations exhibited a mean but not significant decrease in the rate of bone mass loss in comparison with those receiving oxymetholone or a placebo. No hip fractures occurred in the patients who received fluoride, while 11 hip fractures occurred in the patients in the phosphate, oxymetholone, and control groups. Because the densitometric trends and fracture incidence are impressive, the progress of all subjects will be followed for an additional 4 years.

Aged↗
PubMedDate not supplied

Remission of pure red cell aplasia following oxymetholone therapy.

A 53-year-old male with a long-standing idiopathic pure red cell aplasia, refractory to testosterone cypionate, fluoxymesterone, and corticosteroid, was successfully treated with oxymetholone. Blood count, bone marrow, reticuloendothelial bone marrow scan, and ferrokinetic studies showed a marked increase of erythropoiesis in response to oxymetholone. The patient became hematologically normal within 12 weeks and has required no further transfusions. This observation suggests possible difference of mechanisms in the action of various androgenic drugs. It also suggests that failure of response to one androgenic agent does not necessarily mean the other androgenic agents will not be effective in cases of refractory idiopathic pure red cell aplasia.

Anemia, Aplastic↗
PubMed1980

Regression on oxymetholone-induced hepatic tumors after bone marrow transplantation in aplastic anemia.

Treatment of acquired aplastic anemia with androgens has been occasionally associated with the development of hepatic tumors. We have studied a 13-year-old boy with idiopathic aplastic anemia in whom oxymetholone treatment was associated with a partial hematological remission. Thirty-four months later, however, the patient developed multiple hepatic tumors. When oxymetholone therapy was discontinued, the aplastic anemia relapsed. He then underwent bone marrow transplantation from his HLA-A, B, and D-compatible sibling. This was followed by hematological and immunological reconstitution. The hepatic tumors underwent progressive regression after bone marrow transplantation. The patient is now 3 years post-bone marrow transplantation and is in complete remission of his aplastic anemia with no evidence of detectable liver tumors.

Adolescent↗
PubMed1975

Oxymetholone treatment for sickle cell anemia.

Seven patients with sickle cell anemia were treated with oxymetholone for at least 2 mo. Markedly increased basal rates of hemolysis and erythropoiesis were confirmed. The urinary erythropoietin excretion was either normal or lower than expected for the red cell mass, and an expanded blood volume was due primarily to an increased plasma volume. After androgen therapy, six patients demonstrated more than a fivefold increase in urinary erythropoietin, with an increase in red cell mass ranging from 17%-75% above the control value. All showed a decline in serum iron level to the 25-75 mug/100 ml range within 4 wk after the start of therapy. Less marked changes followed lower oxymetholone doses. Reversible hepatic toxicity, with a serum bilirubin concentration exceeding 50 mg/100 ml, occurred in one patient. Androgenic hormone therapy may be useful for selected adult patients with sickle cell disease when severe anemia contributes to disease morbidity.

Adolescent↗
PubMed1992

[Identification of oxymetholone metabolites in the urine using gas chromatography-mass spectrometry].

Metabolite of 17-methyl-17-hydroxy-2-(hydroxymethylen)-androstan-3-one (oxymetholane) in urine after a single oral administration was monitored by gas chromatography+mass spectrometry. During the investigation prepared TMS-ethers and TMS-enol-ethers of conjugated steroid fraction two new metabolites of oxymetholone have been identified: tetrahydrooxymetholone and tetrahydro-6-hydroxy-oxymetholone.

Gas Chromatography-Mass Spectrometry↗
PubMed1976

Hyperlipidemia due to oxymetholone therapy. Occurrence in a long-term hemodialysis patient.

Marked hypertriglyceridemia and hypercholesterolemia accompanied by angina and a left cerebral thrombosis occurred in a long-term hemodialysis patient following 5 1/2 weeks of oral treatment with oxymetholone, 100 mg/day, a synthetic androgen. After androgen therapy was discontinued, over a three-month period, plasma lipid values progressively decreased below pretreatment values, and clinical symptoms disappeared. During rechallenge with oxymetholone, serum lipid values increased substantially, and the lipoprotein pattern changed from a type IV to a type V. Detailed lipid studies showed subnormal postheparin lipolytic activity and a fast-migrating pre-beta-lipoprotein in a very-low-density lipoproteins (VLDL) fraction. Because of the data linking lipid abnormalities to atherosclerosis and the acceleration of atherosclerosis in long-term hemodialysis patients, great caution should be exercised in administering androgenic steroids to these patients.

Acute Kidney Injury↗
PubMed1980

Cytotoxicity of oxymetholone to endothelial cells in vitro.

Morphologic and chromium release studies demonstrated degeneration in monolayer cultures of endothelial cells exposed to the anabolic steroidal hormone oxymetholone. The concentrations approximated those occurring transiently in the hepatic sinusoidal blood after oral administration of the drug during treatment for aplastic anemia. It is suggested that damage to sinusoidal endothelium, with impairment of its ability to maintain sinusoidal collagenous reticulin, is a mechanism by which oxymetholone can cause peliosis hepatis in these patients.

Cells, Cultured↗
PubMed1978

Effect of a single oral dose of oxymetholone on the metabolism of human erythrocytes.

Androgenic steroids have been shown to enhance erythrocyte 2,3-DPG production in vivo and in vitro, and to stimulate the pentose shunt oxidative reactions in vitro. Furthermore, a 3 beta- and a 17 beta-hydroxysteroid dehydrogenase have been identified in red cells. The present study was carried out to explore a cumulative effect of androgens on glycolysis and androgen reduction in human erythrocytes in vivo following a single 50 mg oral dose of 17 beta-hydroxy-2 (hydroxymethylene)-17 methyl-5 alpha-androstan-3-one (oxymetholone). The rate of erythrocyte glycolysis was measured by quantitative determination of: fructose-1,6-diphosphate (FDP); dehydroxyacetone phosphate (DAP); 2,3-diphosphoglycerate (2,3-DPG); adenosine triphosphate (ATP); and lactate. Serum and erythrocyte steroids were separated by thin layer chromatography. The reduction of 5 alpha-androstan-17 beta-ol-3-one by red cell hemolysate was measured in the presence of NADPH as an index of 3(17)beta-hydroxysteroid dehydrogenase activity. Our results show that oxymetholone administration is followed by the appearance of an unidentified steroid fraction in chromatograms of serum and erythrocytes, simultaneously with the enhancement of glycolysis and of hydroxysteroid dehydrogenase activity in erythrocytes. A direct effect of androgen on erythrocyte metabolism, which is independent of the hormone erythropoietic effect, is discussed.

17-Hydroxysteroid Dehydrogenases↗