AIDS TREATMENT NEWS Issue #237, December 22, 1995
John S. James
Oxandrolone was approved by the FDA more than 30 years ago, specifically for regaining weight lost due to infectious disease, among other uses. This approval -- "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" -- is still in force. But despite FDA approval, oxandrolone has long been unavailable in the U.S.; companies chose to drop it instead of meeting the increasing regulatory requirements for anabolic steroids, for a drug which was off-patent and therefore had a low profit margin. Now a small pharmaceutical company, Bio-Technology General Corp. (BTG), has reintroduced oxandrolone for weight gain, and is researching it for four indications for which the drug has orphan-drug status: AIDS wasting, alcoholic hepatitis, Turner's syndrome in girls, and constitutional delay of growth and puberty in boys. A recent double-blind study in 67 patients with AIDS wasting found weight gain with 15 mg/day of oxandrolone for 16 weeks, stable weight with 5 mg, and weight loss with placebo (to be published).
Oxandrolone is relatively expensive, with price to wholesalers being $3.75 to $30 per day, depending on dose. This is a fraction of the cost of human growth hormone ($140/day or more to the patient), which is also used to treat this kind of AIDS-related weight loss due to unknown metabolic changes. The FDA approval for weight loss may help with insurance reimbursement. Much less expensive anabolic steroids are also available; some of them may be comparable to oxandrolone, except that they must be injected. (An early study, which measured anabolic activity by changes in nitrogen excretion in human subjects on a constant diet, found that oxandrolone had about six times the anabolic activity of the same amount of testosterone.(1))
The usual adult dose recommended in the package insert is one 2.5 mg tablet two to four times daily; but the instructions also note that doses as low as 2.5 mg per day or as high as 20 mg per day can be used. (Each 2.5 mg tablet costs $3.75 to the wholesalers.) As with other anabolic steroids, the package insert includes many cautions and warnings of possible adverse effects -- too many to summarize here. But a major controlled study used four times the current approved oxandrolone dose in treating severe alcoholic hepatitis, and reported "no complications attributable to its use."(2)
Oxandrolone is distributed in the U.S. by Quantum Express; it is a Schedule III controlled substance. Quantum Express can handle assignment of benefits (meaning that it will deal directly with insurance companies); and there is a compassionate-access program for those with no insurance or other way to pay. For more information, health-care professionals should call 800/741-2698.
References
1. Fox M, Minot AS, and Liddle GW. Oxandrolone: A Potent Anabolic Steroid of Novel Chemical Composition. JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM. 1962; volume 22, pages 921-924.
2. Mendenhall GL, Moritz TE, Roselle GA and others. A study of oral nutritional support with oxandrolone in malnourished patients with alcoholic hepatitis: Results of a Department of Veterans Affairs cooperative study. HEPATOLOGY 1993; volume 17, number 4, pages 564-576.
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