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• W4248285429 abstract "Carvalho et al report 4 cases of premature thelarche among 83 girls receiving recombinant growth hormone (rGH) since 1995 in Brazil; 2 of 53 had GH deficiency (GHD) and 2 of 30 had Turner's syndrome. Unfortunately, no information on the patients' age or pubertal status was provided. None of the girls with premature thelarche (all ≤8 years old) had precocious puberty. Although all hormonal determinations were within normal limits for age and underlying genetic diagnoses, no vaginal cytologic findings were reported. In all patients, the premature thelarche regressed with GH therapy in <15 months. In one patient with GHD, thelarche recurred 4 months after the resolution of the first episode. No untoward bone age advancement was observed. No gynecomastia was reported among the 76 treated boys. The authors speculate on potential physiopathologic explanations and conclude that although the mechanisms underlying breast development in patients treated with GH remain unknown, it appears to be a benign and self-limited condition. Since the introduction of rGH to the United States market in 1985, the Food and Drug Administration (FDA) has received in excess of 3800 reports of adverse reactions associated with rhGH treatment through the MedWatch surveillance system. Three girls ≤8 years old were reported as having breast enlargement during this period; none of them were from Brazil. In two, precocious puberty was ruled out. No hormonal data were available for the third. In one girl with GHD for whom precocious puberty was ruled out, the bilateral breast enlargement appeared 1 month after initiation of GH therapy and resolved in <6 months during GH therapy. Another girl with GH neurosecretory disorder had Tanner II unilateral breast enlargement. No additional data on these or other patient characteristics were available in these reports. Two reports preceded the first publication in 1995 associating GH with gynecomastia in prepubertal GH-treated boys.1Malozowski S Stadel BV. Prepubertal gynecomastia during growth hormone therapy.J Pediatr. 1995; 126: 659:61Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar Moreover, since 1985, 14 reports of gynecomastia in boys ≤8 years old have been received by the FDA. This paper underscores several points. Awareness of new drug-associated adverse events tends to increase diagnostic scrutiny. In addition, hypotheses of potential mechanisms emerge and maneuvers to ameliorate or treat these events are developed. The data reported by Carvalho et al suggest that estradiol determinations are not contributory in their patients. Although a direct GH effect in the development of the breast has been proposed, the role of estrogens cannot be excluded entirely. Current estrogen assays fail to detect low levels, and transient elevations in estrogen concentration can produce long-term biologic effects on the breast. Vaginal examinations and cytologic studies could provide additional clues as to the presence of systemic estrogens in these patients. Lastly, this study also suggests that in prepubertal patients receiving GH, breast development is more frequent in girls than in boys. The FDA database suggests the opposite, but there may be an ascertainment bias given the prior reports on the association between GH and gynecomastia in men and boys and the lack of previous information in girls. When the initial report on GH and prepubertal gynecomastia was drafted,1Malozowski S Stadel BV. Prepubertal gynecomastia during growth hormone therapy.J Pediatr. 1995; 126: 659:61Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar no reports of premature thelarche and GH treatment were available at the FDA. When the first accounts were filed, a strong cause-and-effect relationship between GH treatment and thelarche could not be established, given the common occurrence of premature thelarche in the general population and the paucity of information in the existing reports. The series by Carvalho et al, however, further supports the association between GH administration and breast development in prepubertal children and gives more credence to the belief that breast development during GH treatment appears benign and self-limited. To properly assess the true incidence of breast development during GH therapy, it may be desirable to prospectively follow up both boys and girls receiving GH with routine breast examinations. Disclaimer: The contents of this reply reflect the position of the authors and do not constitute an official position of the US Food and Drug Administration. 9/35/109105" @default.
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• W4248285429 date "2001-03-01" @default.
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