2005N-0404 Solicitation of Public Review and Comment on Research Protocol:
FDA Comment Number : EC4
Submitter : Ms. Melissa Harry Date & Time: 11/08/2005 08:11:47
Organization : Ms. Melissa Harry
Category : Individual Consumer
Issue Areas/Comments
To Whom it May Concern,

I am writing in opposition to use of Gonadotropin Relasing Hormone (GnRH) agonist testing in disorders of puberty. Having personally spent 9 months on the GnRH treatment Leueprolide Acetate, I understand all too well the safety and ethical issues involved in the use of GnRH agonists on children, as I suffered from serious GnRH side effects. I believe enough research has been published formally in journal articles to warrant discretion in the use of GnRH on vulnerable populations such as children. I am including a number of these articles for your review. (See attachment for full listing of articles)

Melissa Harry

Rao LV, Cleveland RP, Ataya KM. Alterations in thymic and bone marrow lymphocyte subpopulations in GnRh agonist treated prepubertal female mice. American Journal of Reproductive Immunology. 25 : 1993

[Federal Register: May 1, 1996 (Volume 61, Number 85)]
[Page 19295-19296]
Findings of Scientific Misconduct
FOR FURTHER INFORMATION CONTACT: Director, Division of Research
Investigations, Office of Research Integrity, 5515 Security Lane, Suite
700, Rockville, MD 20852.
Chris B. Pascal,
Acting Director, Office of Research Integrity.
[FR Doc. 96-10731 Filed 4-30-96; 8:45 am]

Leuprolide-induced myopathy.
Van Gerpen JA, McKinley KL.
PMID: 12366635 [PubMed - indexed for MEDLINE]

Rao LV, Cleveland R, McMullen S, Hagen R, Ataya K. Effect of GnRH Agonist on Sequential Changes in Peripheral Blood Leucocyte Subpopulations in Women With Endometriosis and/or Uterine Fibroids. Fertility & Sterility . 1994

Grau E, Torrecila T, Real E, Sempere J. Leukopenia induced by leuprolide acetate depot. Annals of Pharmacotherapy. 28: 1994

Am J Obstet Gynecol 2000 Jul;183(1):58-62
Increase in serum leptin concentrations among women with endometriosis during danazol and leuprolide depot treatments.
Matalliotakis IM, Koumantaki YG, Neonaki MA, Goumenou AG, Koumantakis GE, Kyriakou DS, Koumantakis EE
PMID: 10920309, UI: 20380528

Thyroid. 2003 Aug;13(8):815-8. Related Articles, Links

Possible induction of Graves' disease and painless thyroiditis by gonadotropin-releasing hormone analogues.
Amino N, Hidaka Y, Takano T, Tatsumi KI, Izumi Y, Nakata Y.
PMID: 14558924 [PubMed - in process]

Newton C, Slota D, Yuzpe AA, Tummon IS. Memory complaints associated with the use of gonadotropin-releasing hormone agonists: a preliminary study. Fertility & Sterility. 1996

Varney NR, Syrop C, Kubu CS, Struchen M, Hahn S, Franzen K. Neuropsychologic Dysfunction in Women Following Leuprolide Acetate Induction of Hyproestrogenism. Journal of Assisted Reproduction and Genetics, 1993

Friedman AJ, Juneau-Norcross M, Rein MS. Adverse effects of leuprolide acetate depot treatment. Fertility & Sterility. 1993

Effects of gonadotropin-releasing hormone analog treatment on skin condition.
Gynecol Endocrinol. 2002 Feb;16(1):57-61.
PMID: 11915583 [PubMed - indexed for MEDLINE]

Bone metabolism in postmenopausal women who were treated with a gonadotropin-releasing hormone agonist and tibolone.
Fertil Steril. 2002 Jul;78(1):63-8.
PMID: 12095492 [PubMed - indexed for MEDLINE]

Pituitary haemorrhage after leuprolide therapy for prostatic cancer, clinically imitating acute subarachnoidal haemorrhage.
Cerebrovasc Dis. 2002;14(3-4):272.
PMID: 12403969 [PubMed - indexed for MEDLINE

Exacerbation of lupus nephritis in association with leuprorelin injection for uterine leiomyoma.
Metcalfe W, Boulton-Jones JM.
PMID: 9269652 [PubMed - indexed for MEDLINE]

Drugs recently associated with lupus syndromes.
Fritzler MJ.
PMID: 7704001 [PubMed - indexed for MEDLINE]

TAP Pharmaceuticals pleads to "deliberate fraud"
By Leslie Gevirtz
BOSTON, Oct 16 (Reuters)

Chitosan-coated liposomes: characterization and interaction with leuprolide.
Guo J, Ping Q, Jiang G, Huang L, Tong Y.
PMID: 12842337