FDA Reproductive Health Drug Advisory Committee Meeting August 29, 2006 Gaithersburg, Maryland

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FDA Reproductive Health Drug Advisory Committee Meeting August 29, 2006 Gaithersburg, Maryland

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New Drug Application for "Gestiva" 17 alpha-hydroxyprogesterone caproate (17 P) Theresa Grossklaus, RN, BA, BSN Current Master of Science of Nursing Student

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Before endorsing NDA 21-945… … consider lessons gained from 17 P's earlier use under the brand name "Delalutin"

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Prior utilization of "17 P" 1980s 3 pregnancies Treatment of various condition Use amid various development weeks of pregnancy

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Delalutin

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Treatment of Suspected Corpus Luteum Insufficiency

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Supplement affirmed pregnancy with Progesterone vaginal suppositories Weekly infusions of Delalutin (17 P ) 250 mg IM Gestation weeks ~ 5-9 or 5-12 Modified: incubation weeks 5-17, 5-18

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Outcome: 3 kids

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Concerns – Delalutin (17 P)

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Possible unfriendly connection amongst liquor and 17 P when utilized for treatment of corpus luteum deficiency amid incubation weeks 5-18

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A most impossible to miss pregnancy described by 4 issues: Congenital cardiovascular condition Primary microcephaly Intrauterine development impediment A maternal "drinking issue"

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Our child, 1986 & 1991

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1991… Conducted an audit of writing on birth deserts related with progestins, and with liquor, conceivable components of teratogenesis, intrinsic heart conditions, microcephaly, behavioral teratology, intrauterine development hindrance, liquor digestion system, habit, & more

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Subjective experience "dependence" to liquor by 15-17 weeks No inebriation Sensation of fetal development confinement inside 1 week of "enslavement" Symptoms decrease between 18-21 weeks Symptoms quicken following 21 weeks Intense habitual drinking issue ejects ~ 26 weeks "It's all my blame for savoring the 3 rd trimester"

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Oversimplified legitimate clarification Alcohol is a 2 layered psychotropic medication which requires change from ethanol to acetaldehyde Ethanol is metabolized yet the digestion system of acetaldehyde is limited

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Possible clarification Acetaldehyde aggregates in mother's mind, liver, and serum – Acetaldehyde fills in as a teratogen, a fetal development inhibitor, a disruptor of steroid hormone biosynthesis, an addicting substance for mother, and an inhibitor of fetal cerebrum development

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Treatment of corpus luteum inadequacy with 17 alpha-hydroxyprogesterone caproate (17 P) with likely complexities because of pre-birth liquor utilization: a 1991 point of view

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Request postponement of endorsement of NDA 21-945 until an assigned medicinal analyst can survey this composition (>600 pages) and evaluate appropriateness to this more up to date utilization of 17 P

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Birth imperfections are typically connected with first trimester introduction to teratogens… Brain development and relocation of neurons can be repressed by liquor amid pregnancy (counting 2 nd & 3 rd trimesters) Maternal "fixation" to liquor may be conceivable whenever amid pregnancy

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… If both of our 2 girls were pregnant and 17 P supplementation was prescribed to them, I would need them to be extremely all around educated about this conceivable result, and be given a particular cautioning not to devour one piece of liquor while on 17 P.

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Consider assurance for… Fetus Mother Prescribing doctor Pharmaceutical mfg.

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Prospective method for catching results of pregnancies presented to progesterone Uniform, particular cautioning could be conveyed to pregnant patients to maintain a strategic distance from liquor while on 17 P while getting a marked assent Adverse impacts could be nearly observed Longitudinal information could be followed Pregnancy Exposure Registry

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Before supporting NDA-21-945… … if a pregnant lady on 17 P got to be "dependent" and built up "a drinking issue" how could an expert recognize this? … how could this expert treat or intercede?

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I am thankful for the chance to tolerate three kids

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