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Re: pregnancy and condylomaFrom: Braun, R. Daniel (rbraun@iupui.edu)Mon Feb 22 04:33:24 1999
Because of the long argued over study of Nora & Nora back in the 70's which showed an association of Provera with VACTERL Syndrome. Dan R. Daniel Braun, MD FACOG Clinical Professor Department of Obstetrics and Gynecology Indiana U. School of Medicine Indianapolis, IN -----Original Message----- From: Roger Klam, M.D. [SMTP:tstork2@intrnet.net] Sent: Sunday, February 21, 1999 6:21 PM To: Multiple recipients of list Subject: RE: pregnancy and condyloma Does anyone know why progesterone is class x? Roger Klam, M.D. -----Original Message----- From: ob-gyn-l@obgyn.net [mailto:ob-gyn-l@obgyn.net]On Behalf Of Braun, R. Daniel Sent: Tuesday, February 16, 1999 4:46 AM To: Multiple recipients of list Subject: RE: pregnancy and condyloma Key to FDA Useinpregnancy Ratings The Food and Drug Administration's Pregnancy Categories are based on the degree to which available information has ruled out risk to the fetus, balanced against the drug's potential benefits to the patient. Ratings range from "A," for drugs that have been tested for teratogenicity under controlled conditions without showing evidence of damage to the fetus, to "D" and "X" for drugs that are definitely teratogenic. The "D" rating is generally reserved for drugs with no safer alternatives. The "X" rating means there is absolutely no reason to risk using the drug in pregnancy. CATEGORY INTERPRETATION A Controlled studies show no risk. Adequate, wellcontrolled studies in pregnant women have failed to demonstrate risk to the fetus. B No evidence of risk in humans. Either animal findings show risk, but human findings do not; or, if no adequate human studies have been done, animal findings are negative. C Risk cannot be ruled out. Human studies are lacking, and animal studies are either positive for fetal risk, or lacking as well. However, potential benefits may justify the potential risk. D Positive evidence of risk. Investigational or postmarketing data show risk to the fetus. Never the less, potential benefits may outweigh the potential risk. x Contraindicated in pregnancy. Studies in animals or human, or investigational or postmarketing reports have shown fetal risk which clearly outweighs any possible benefit to the patient. The above is scanned directly out of the PDR. R. Daniel Braun, MD FACOG Clinical Professor Department of Obstetrics and Gynecology Indiana U. School of Medicine Indianapolis, IN -----Original Message----- From: Pat Sonnenstuhl [SMTP:webmidwife1@home.com] Sent: Monday, February 15, 1999 6:53 PM To: Multiple recipients of list Subject: Re: pregnancy and condyloma I have a slightly different list of definitions for these terms: Cat A: Adequate studies in pregnant women...no evidence of risk... Cat B: Animal studies have failed to show a risk to the fetus, but there are no adequate studies... Cat C: Animal Studies have shown an adverse affect on the fetus but there are no adequate studies... Cat D: Positive evidence of human fetal risk but the benefits may outweigh the risks. Cat X: Animal or human studies have shown fetal abnormalities or toxicity, and the risk outweighs the benefits. Nurse Practitioners Prescribing Reference
-- Braun, R. Daniel wrote: > > Pregnancy Category A = RCT's in humans have shown no
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