title: Aseptic necrosis in HIV seropositive patients: a possible etiologic role for megestrol acetate.
abstract: The association between pharmacologic doses of corticosteroids and the development of aseptic bone necrosis has been well documented. Recent reports have described the corticosteroid activity of megestrol acetate. A retrospective review of adverse events reported to the U.S. Food and Drug Administration identified three human immunodeficiency virus (HIV) seropositive patients who developed avascular necrosis of the femoral head during treatment with megestrol acetate. All were males, ages 34, 36, and 55 years, and were on therapy for 6, 1.5, and 18 months, respectively, when symptoms of aseptic necrosis occurred in the absence of antecedent trauma. Megestrol acetate doses were 640, 320, and 600-1200 mg/d, respectively. Two patients had no history of corticosteroid use whereas the third had taken an undisclosed dose and duration of corticosteroids concurrent with pentamidine administration. Notably, despite the predominant use of megestrol in women for hormone sensitive malignancies, none of the reports of aseptic necrosis occurred in this population. Megestrol acetate may be associated with the development of avascular necrosis via its glucocorticoid-like effects. Cachectic acquired immunodeficiency syndrome (AIDS) patients may have additional risk factors that predispose them to aseptic necrosis when receiving megestrol acetate.
authors.affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA. Kollere@cder.fda.gov
authors.forename: E
authors.initials: E
authors.lastname: Koller
authors.forename: M
authors.initials: M
authors.lastname: Mann
authors.forename: S
authors.initials: S
authors.lastname: Malozowski
authors.forename: J
authors.initials: J
authors.lastname: Bacsanyi
authors.forename: C
authors.initials: C
authors.lastname: Gibert
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D015984:Causality; D005271:Femur Head Necrosis / Q000139:chemically induced* / Q000175:diagnosis / Q000821:virology; D019247:HIV Wasting Syndrome / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D019290:Megestrol Acetate / Q000009:adverse effects*; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D019290:Megestrol Acetate