Maternal drug histories and congenital abnormalities.

Greenberg, Grant M.; Inman, W. H. W.; Weatherall, Josephine A. C.; Adelstein, A. M.; Haskey, J

doi:10.1136/bmj.2.6091.853

Cited by 105 publications

(31 citation statements)

References 10 publications

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“…Significantly fewer controls reported exposure. A relationship was also found between progestins and overall anomaly rates in a study by Greenberg et al [10]; cardiac anomalies were among the birth defects responsible for this finding.…”

Section: Cardiac Anomaliesmentioning

confidence: 52%

“…The association was not siL,-nificant when oral contraceptives were considered separately. Greenberg et al [10] found an overall increase in anomalies following progestogen exposure; limb reduction defects contributed to this increase. More recently, a retrospective case-control study in Australia by Kricker et al [41] claimed an association between oral contraceptive use and limb abnormalities.…”

Section: /428 (3-5%)mentioning

confidence: 97%

“…Only 4 of 100 controls recalled hormone exposure (p<0.01). Greenberg et al [10] claimed a possible relationship between NTD and hormone exposure, 25 of 93 infants with NTD having a history of hormone exposure. An important variable ignored in the study by Gal was prior reproductive history, especially relevant in the United Kingdom because of its high incidence of NTD.…”

Section: Neural Tube Defects and Hydrocephalusmentioning

confidence: 98%

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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: Cardiac Anomaliesmentioning

confidence: 52%

Section: /428 (3-5%)mentioning

confidence: 97%

Section: Neural Tube Defects and Hydrocephalusmentioning

confidence: 98%

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Spermicides, hormonal contraception and congenital malformations

Simpson

Phillips

1990

Adv Contracept

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“…Evidence of a strong association was obtained for cases of congenital cardiac malformation (RR: 5.38; p < 0.01). Increased frequency of neural tube defects combining both the use of oral contraceptives and other forms of hormone exposure (associated with treatment of threatened abortion, hormone failure, anti-cancer treatment, and pregnancy tests, among others) have been described (Greenberg et al, 1977;Janerich et al, 1980;Nora et al, 1978).…”

Section: Evidence Of Association Between Oral Hormones and Orofacial mentioning

confidence: 99%

Chemical exposure during pregnancy and oral clefts in newborns

2002

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“…None of the epidemiological studies described a "progestational non-genital organ teratogenic syndrome." You will also note that many of the studies with negative results were published before 1977 (Boldt, 1976;Bracken et al, 1978;Briggs and Briggs, 1979;Burstein and Wasserman, 1964;Castilla et al, 1979;Check et al, 1985Check et al, , 1986Correy et al, 1991;Czeizel et al, 1983;Czeizel and Kodaj, 1995;Darling and Hawkins, 1981;Ferencz et al, 1980;Goujard and Remeau-Roquette, 1977;Gray and Pardthaisong, 1991;Greenberg et al, 1975Greenberg et al, , 1977Katz et al, 1985;Haller, 1974;Harlap and Eldor, 1980;Harlap et al, 1975Harlap et al, , 1985Heinonen et al, 1977b;Janerich, 1979, Janerich et al, 1977, 1980Kasan and Andrews, 1980;Lammer et al, 1986;Linn et al, 1983;Martinez-Frias, 1998;Matsunaga and Shiota, 1979;Michaelis et al, 1983;Mitchell et al, 1992;Mulvihill et al, 1974;Newman et al, 1977;Oakley, 1979aOakley, , b, 1984Oakley et al, 1973;Oechsli, 1976;Pardthaisong et al, 1988…”

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

confidence: 95%

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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Maternal drug histories and congenital abnormalities.

Cited by 105 publications

References 10 publications

Spermicides, hormonal contraception and congenital malformations

Spermicides, hormonal contraception and congenital malformations

Chemical exposure during pregnancy and oral clefts in newborns

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

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