The Relationship Between Congenital Defects and the Use of Exogenous Progestational “Contraceptive” Hormones During Pregnancy: A 20‐Year Review

Keith, Louis; Berger, Gary S.

doi:10.1002/j.1879-3479.1977.tb00659.x

Cited by 22 publications

(6 citation statements)

References 25 publications

(16 reference statements)

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“…Critical assessment leads one to conclude that neither contraceptive method increases fetal risks over the 2-3% anomaly rate for any pregnancy in the general population. Our conclusions are consistent with the authors' earlier assessment [1] as well as extensive reviews by others [54][55][56][80][81][82][83][84].…”

Section: Resultssupporting

confidence: 95%

Spermicides, hormonal contraception and congenital malformations

Simpson

Phillips

1990

Adv Contracept

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Allegations that inadvertent pregnancies in contraceptive users are associated with congenital anomalies continue to be common. In 1985, a review by one of us concluded that there is little or no scientific basis for such claims [1]. Since then, additional data have substantiated this conclusion, particularly with respect to spermicides and hormonal contraception. The purpose of this review is to update information with respect to potential teratogenicity for these two contraceptive methods.

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Section: Resultssupporting

confidence: 95%

Spermicides, hormonal contraception and congenital malformations

Simpson

Phillips

1990

Adv Contracept

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“…There may be an increase in risk of congenital heart disease up to twofold [66] and possibly also in central-nervous-system malformations. Norethisterone does appear to have a weak androgenic effect in humans, but is minimal with lower doses or shorter exposure [69]. On the other hand, exposure to massive doses of norethisterone (10-40 mg daily) from the 4th to the 35th week of pregnancy was associated in one study with some degree of virilization among 18% of female infants born to 82 mothers [68].…”

Section: Fetal Exposurementioning

confidence: 95%

Systemic hormonal contraception by non-oral routes

Fraser¹

1989

Contraception

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“…A number of review articles that dealt with the teratogenicity of progestational drugs were also published in the 1970s and 1980s, and the consensus of these publications did not support the idea that progestational drugs can produce nongenital malformations (Ambani et al, 1977;Aro et al, 1984;Bracken, 1990;Benagiano and Fraser, 1981;Brent, 1989;Briggs and Briggs, 1979;Chez, 1978;Corfman, 1988;Darling and Hawkins, 1981;Kallén et al, 1984;Kalter and Warkany, 1983;Keith and Berger, 1977;McDonough, 1985;Nocke, 1978;Raman-Wilms et al, 1995;Schardein, 1980;Scialli, 1988;Simpson, 1985;Smithells, 1981;Stakemen et al, 1984;Wilson and Brent, 1981;World Health Organization, 1981;World Health Organization Scientific Group, 1986).…”

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

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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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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The Relationship Between Congenital Defects and the Use of Exogenous Progestational “Contraceptive” Hormones During Pregnancy: A 20‐Year Review

Cited by 22 publications

References 25 publications

Spermicides, hormonal contraception and congenital malformations

Spermicides, hormonal contraception and congenital malformations

Systemic hormonal contraception by non-oral routes

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

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