A very typical case of severe cholestasis due to anabolic steroid use. Because the steroids were being used without medical supervision, the dose and actual duration of use of each preparation was unclear, but cholestasis usually arises within 4 to 12 weeks of starting a C-17 alkylated androgenic steroid. The jaundice can be severe and prolonged and accompanied by severe pruritus and marked weight loss. The serum enzymes are typically minimally elevated except for a short period immediately after stopping therapy. The pattern of enzyme elevations can be hepatocellular, cholestatic or mixed. Liver biopsy shows a “bland” cholestasis with minimal inflammation and hepatocellular necrosis. Ma Huang has also been implicated in cases of drug induced liver injury, but is associated with an acute hepatocellular pattern of injury.
However, in December 2004 the United States the 14-member Food and Drug Administration (FDA) advisory committee, plus voting consultants, for Reproductive Health Drugs unanimously rejected Procter and Gamble's fast-track request for Intrinsa citing concerns about off-label use . In Canada, post-menopausal women have been able to obtain government-approved testosterone treatment since 2002. In Australia, post-menopausal women can use Organon testosterone implants which have to be surgically inserted and last from three to six months.