BOXED WARNING
PELIOSIS HEPATIS, A CONDITION IN WHICH LIVER AND SOMETIMES SPLENIC TISSUE IS REPLACED WITH BLOOD-FILLED CYSTS, HAS BEEN REPORTED IN PATIENTS RECEIVING ANDROGENIC ANABOLIC STEROID THERAPY. THESE CYSTS ARE SOMETIMES PRESENT WITH MINIMAL HEPATIC DYSFUNCTION, BUT AT OTHER TIMES THEY HAVE BEEN ASSOCIATED WITH LIVER FAILURE. THEY ARE OFTEN NOT RECOGNIZED UNTIL LIFE-THREATENING LIVER FAILURE OR INTRA-ABDOMINAL HEMORRHAGE DEVELOPS. WITHDRAWAL OF DRUG USUALLY RESULTS IN COMPLETE DISAPPEARANCE OF LESIONS. LIVER CELL TUMORS ARE ALSO REPORTED. MOST OFTEN THESE TUMORS ARE BENIGN AND ANDROGEN-DEPENDENT, BUT FATAL MALIGNANT TUMORS HAVE BEEN REPORTED. WITHDRAWAL OF DRUG OFTEN RESULTS IN REGRESSION OR CESSATION OF PROGRESSION OF THE TUMOR. HOWEVER, HEPATIC TUMORS ASSOCIATED WITH ANDROGENS OR ANABOLIC STEROIDS ARE MUCH MORE VASCULAR THAN OTHER HEPATIC TUMORS AND MAY BE SILENT UNTIL LIFE-THREATENING INTRA-ABDOMINAL HEMORRHAGE DEVELOPS. BLOOD LIPID CHANGES THAT ARE KNOWN TO BE ASSOCIATED WITH INCREASED RISK OF ATHEROSCLEROSIS ARE SEEN IN PATIENTS TREATED WITH ANDROGENS OR ANABOLIC STEROIDS. THESE CHANGES INCLUDE DECREASED HIGH-DENSITY LIPOPROTEINS AND SOMETIMES INCREASED LOW-DENSITY LIPOPROTEINS. THE CHANGES MAY BE VERY MARKED AND COULD HAVE A SERIOUS IMPACT ON THE RISK OF ATHEROSCLEROSIS AND CORONARY ARTERY DISEASE.
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OXANDRIN SUMMARY
Oxandrin®(oxandrolone tablets, USP)CIII
OXANDRIN® oral tablets contain 2.5 mg or 10 mg of the anabolic steroid oxandrolone.
Oxandrin is indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis (See DOSAGE AND ADMINISTRATION).
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NEWS HIGHLIGHTS
Published Studies Related to Oxandrin (Oxandrolone)
The effects of oxandrolone and exercise on muscle mass and function in children with severe burns. [2007.01]
CONCLUSIONS: Oxandrolone, in combination with exercise, is beneficial in severely burned children, thus improving their rehabilitation.
Effects of oxandrolone on outcome measures in the severely burned: a multicenter prospective randomized double-blind trial. [2006.03]
Severe burns induce pathophysiologic problems, among them catabolism of lean mass, leading to protracted hospitalization and prolonged recovery. Oxandrolone is an anabolic agent shown to decrease lean mass catabolism and improve wound healing in the severely burned patients... We conclude that treatment using oxandrolone should be considered for use in the severely burned while hepatic transaminases are monitored.
Oxandrolone in the treatment of HIV-associated weight loss in men: a randomized, double-blind, placebo-controlled study. [2006.03]
OBJECTIVE: To evaluate the efficacy and safety of oxandrolone in promoting body weight and body cell mass (BCM) gain in HIV-associated weight loss... CONCLUSION: Oxandrolone administration is effective in promoting dose-dependent gains in body weight and BCM in HIV-infected men with weight loss.
Metabolic and hormonal changes of severely burned children receiving long-term oxandrolone treatment. [2005.09]
OBJECTIVE: When given to children for 1 year after a severe burn, oxandrolone significantly improves lean body mass, bone mineral content, and muscle strength. The beneficial effects of oxandrolone on height and weight were observed 1 year after treatment was discontinued. To study the efficacy of oxandrolone in severely burned children for 12 months after burn and 12 months after the drug was discontinued. SUMMARY BACKGROUND DATA: Oxandrolone attenuates body catabolism during the acute phase after burn. It is unclear whether oxandrolone would have any beneficial effects during long-term treatment or if there were any effects after the drug was stopped... CONCLUSIONS: Oxandrolone improved body composition and strength in severely burned children during the 12 months of treatment. Its effect on height and weight continued after treatment was discontinued.
Oxandrolone does not improve outcome of ventilator dependent surgical patients. [2004.09]
BACKGROUND: Multisystem injury and major surgical stress result in a hypermetabolic state with accelerated breakdown of protein stores. Loss of lean muscle mass impairs wound healing, increases infection rates, and weakens respiratory musculature. Oxandrolone is an anabolic steroid that attenuates loss of lean body mass and improves wound healing in burn patients. We hypothesized that oxandrolone would improve outcome for ventilator-dependent surgical patients... CONCLUSION: Ventilator-dependent surgical patients receiving oxandrolone had a more prolonged course of mechanical ventilation, suggesting that oxandrolone may be detrimental in this circumstance. Oxandrolone may enhance collagen deposition and fibrosis in the later stages of acute respiratory distress syndrome and thus prolong recovery.
Clinical Trials Related to Oxandrin (Oxandrolone)
Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions [Completed]
Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer [Active, not recruiting]
RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life
in patients with cancer. It is not yet known whether oxandrolone is more effective than
megestrol in preventing weight loss and improving quality of life in patients who are
receiving chemotherapy for solid tumors.
PURPOSE: This randomized phase III trial is studying oxandrolone to see how well it works
compared to megestrol in preventing weight loss and improving quality of life in patients who
are receiving chemotherapy for solid tumors.
Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome [Active, not recruiting]
RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X
chromosome and do not produce the hormones estrogen and androgen. Giving growth hormone may
help girls with Turner's syndrome attain a more normal height. It is not yet known if growth
hormone is more effective with or without oxandrolone for Turner's syndrome.
PURPOSE: Randomized phase II trial to study the effectiveness of oxandrolone in girls who
have growth hormone-treated Turner's syndrome.
The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury [Completed]
The purpose of this study is to determine the effect of oxandrolone on the function and
quality of life of patients with chronic spinal cord injury.
Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD) [Completed]
This is a study to determine whether albuterol or oxandrolone, alone or in combination, are
able to increase strength and muscle mass in patients with FSHD. It also will determine if
albuterol given in "pulsed" fashion will have more effect than when given continuously.
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