The relationship of threatened abortion to fetal abnormalities

Burge, Erin

doi:10.1016/0002-9378(51)91409-3

Cited by 20 publications

(3 citation statements)

References 14 publications

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“…The frequency of congenital malformations was similar in the 1608 mothers who were treated with progestins (1274 received MPA) and the 1146 untreated pregnant women. The inclusion in the control population of women who had experienced vaginal bleeding during the first trimester is most important because the rate of malformations following first-trimester hemorrhage is increased compared to that in the general population (Brent and Franklin, 1960;Brent, 1990Brent, , 1993bBurge, 1951;Funderburk et al, 1980;Matsunaga and Shiota, 1979;Nishimura et al, 1974;Nishimura, 1970;Oakley, 1979a, b;Ornoy et al, 1976;Peckham, 1970;South, 1973;National Institute of Child Health and Human Development Workshop, 1993;Turnbull and Walker, 1956). Katz et al (1985) provided data indicating that no increase in nongenital congenital malformations was noted in women treated with progestogens compared to cohort control groups.…”

Section: -1987: Effect Of the Fda Package Insert Warningmentioning

confidence: 96%

“…Although there has been some disagreement about whether pregnancy bleeding increases the risk of congenital malformations (Aro et al, 1984;Asanti and Vesanto, 1963;Burge, 1951;Evans and Beicher, 1970;Funderburk et al, 1980;King, 1953;Kotz et al, 1941;Shiota, 1979, 1980;Nishimura, 1970;Nishimura et al, 1974;Ornoy et al, 1976;Peckham, 1970;Smith et al, 1977;South, 1973;Stevenson et al, 1950;Turnbull and Walker, 1956), only a few investigators thought that the bleeding was responsible for the malformations. Turnbull and Walker (1956) stated, "[w]hether or not bleeding in the early months of pregnancy is a significant cause of fetal deformity remains unsettled."…”

Section: In the Teratogenic Animal Model Does The Frequency Of Malfomentioning

confidence: 96%

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Nongenital malformations following exposure to progestational drugs: The last chapter of an erroneous allegation

Brent

2005

Birth Defect Res A

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In the late 1960s and 1970s, a number of epidemiological studies were published indicating that pregnant women who were exposed to an array of sex steroids delivered infants with an increased incidence of nongenital congenital malformations. Because of these publications, the Food and Drug Administration (FDA), in conjunction with various pharmaceutical companies, labeled the therapeutic exposure of progestational drugs and contraceptives in pregnant women as a risk factor for limb-reduction defects (LRDs) and congenital heart defects (CHDs). Subsequently there was a rapid decrease in the exposure of pregnant women to these drugs and the initiation of numerous lawsuits alleging that a particular progestational drug was responsible for a child's nongenital congenital malformation. Wilson and Brent (1981) published an article indicating that epidemiological and animal studies of these drugs, and basic science did not support the package insert's warnings. Many new and previous animal and epidemiological studies did not support the FDA box warning. In 1987 the FDA held a hearing in which the FDA, the Teratology Society, the Centers for Disease Control and Prevention, the American College of Obstetrics and Gynecology, and other organizations supported the position that progestational agents did not result in nongenital malformations. An editorial appeared in Teratology congratulating the FDA for removing the warning label on oral contraceptives regarding nongenital malformations. In 1999 the FDA published new wording for package inserts that removed warnings for nongenital malformations for all progestational agents. In spite of the recent changes in the package inserts, lawsuits have alleged that progestational drugs cause nongenital malformations. It took 22 years from the time a box warning was required by the FDA until the warnings were removed in 1999. The 1999 FDA publication, which is a scholarly and objective document, should put an end to 2 decades of concern and anxiety for pregnant women or women of reproductive age. Could scientists, the pharmaceutical companies, or the FDA have prevented the mislabeling of progestational drugs with regard to their teratogenic risks? Was the epidemiological or teratology community at fault because they did not critique and respond to the early publications? Did the FDA act too slowly? The epidemiologic analyses, animal studies, and basic science principles have been reviewed, and it is obvious that clinically utilized progestational drugs do not cause nongenital malformations (i.e., LRDs and CHDs).

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Section: -1987: Effect Of the Fda Package Insert Warningmentioning

confidence: 96%

Section: In the Teratogenic Animal Model Does The Frequency Of Malfomentioning

confidence: 96%

Nongenital malformations following exposure to progestational drugs: The last chapter of an erroneous allegation

Brent

2005

Birth Defect Res A

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“…Eight precepts pertaining to hemorrhage in the first and second trimesters were elucidated: ( 1) Bleeding in pregnancy is never normal; ( 2) more mistakes in diagnosis are made by not looking than by not knowing; ( 3) in her handling of abortion, nature is usually more wise than obstinate; ( 4) any bleeding during the early weeks of gestation should he regarded as being caused either by abortion or by tubal pregnancy; ( 5) there is no expected treatment for a growing ectopic gestation; ( 6) early and prompt diagnosis will prevent practically all deaths from ruptured tubal pregnancy; ( 7) hemorrhage produces anemia and anemia produces hemorrhage; and ( 8) if mortality from obstetric hemorrhage is ever to he reduced, attention to hemoglohin and the blood count must equal that given to urine and blood pressure, and to blood loss, that given to asepsis.…”

Section: August 1963mentioning

confidence: 99%