[e-drug] Compounded drug warnings issued on hormones; inhalation meds (3)

["Sarah Sellers" <sarahsellers@mac.com>]

E-DRUG: Compounded drug warnings issued on hormones; inhalation meds (3)
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Dear E-Drug Colleagues,

There are numerous FDA-approved products available in the US with  
adequate labeling for safe use, including topicals, for women who must  
resort to pharmacologic interventions for the management of menopausal  
symptoms.  The risks associated with compounded products have not been  
evaluated, however, sentinel events should give prescribers pause  
before resorting to non-commercial formulations:

Felner and White report a case series of prepubertal gynecomastia  from  
indirect exposure to custom-compounded estrogen cream used by each  
child's mother and conclude:

Indirect exposure to excessive amounts of topical estrogen may cause  
gynecomastia, rapid changes in growth, and advanced bone age in  
prepubertal children. Because custom-compounded topical estrogen  
preparations are not regulated by the Food and Drug Administration and  
may contain high concentrations of estrogen, we recommend that women  
requiring estrogen use an alternate form of estrogen delivery if they  
are in frequent contact with children.

See: Felner EI, White P. Prepubertal gynecomastia: Indirect exposure to  
estrogen cream. Pediatrics 2000; 105(55) [on-line].

Sarah Sellers PharmD MPH
121 Rose Terrace
Barrington, IL 60010
ssellers@jhsph.edu
847-526-2248