Hormonal Pregnancy Tests and Neural Tube Malformations

Laurence, Michael; Miller, Mary Helen; Vowles, M; Evans, Kathleen; Carter, Cedric

doi:10.1038/233495b0

Cited by 39 publications

(8 citation statements)

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“…No significant increase was seen in a United Kingdom study by Laurence et al [51], whose study population was larger than that of Gal et al [50]. Other large negative case-control studies include those of Bracken et al [11] in Conneticut (Table 1) and Lammer and Cordero [43] in Georgia (Table 4).…”

Section: Neural Tube Defects and Hydrocephalusmentioning

confidence: 85%

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: Neural Tube Defects and Hydrocephalusmentioning

confidence: 85%

Spermicides, hormonal contraception and congenital malformations

Simpson

Phillips

1990

Adv Contracept

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“…A United Kingdom study was that of Laurence et al [40], who showed no significant increase in a sample much larger than that of Gal et al [39]. Another large negative case study is that of Bracken et al [26].…”

Section: Neural Tube Defects (Ntd)mentioning

confidence: 94%

Relationship between congenital anomalies and contraception

1985

Adv Contracept

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“…Such tests had also been used in 22 of 323 control pregnancies that produced normal children, and the difference between these groups was not statistically significant. Following the report of Laurence et al (1971), Gal (1972) reexamined their previously reported data and concluded that even when such factors as maternal age and reproductive history were controlled for, there was still a significant association between NTDs and exposure to sex hormones during pregnancy. Laurence (1972) and Sever (1973) further criticized Gal's (1967Gal's ( , 1972 analysis, noting that most pregnancy tests in Gal's series were administered after the closure of the neural tube, and therefore were unlikely to have produced some of the reported nervous system malformations.…”

Section: -1976: Epidemiological Studies Of Sex Steroid Exposure Amentioning

confidence: 85%

“…Investigators in the 1960s and 1970s were not aware that the percentage of pregnancies with sex steroid exposure was much higher in the control pregnancies. In a similar but larger retrospective study, which also involved nervous system malformations, 271 pregnancies resulting in NTDs were found to include only 22 pregnancies that had been diagnosed with hormonal pregnancy tests (Laurence et al, 1971). Such tests had also been used in 22 of 323 control pregnancies that produced normal children, and the difference between these groups was not statistically significant.…”

Section: -1976: Epidemiological Studies Of Sex Steroid Exposure Amentioning

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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Hormonal Pregnancy Tests and Neural Tube Malformations

Cited by 39 publications

References 1 publication

Spermicides, hormonal contraception and congenital malformations

Spermicides, hormonal contraception and congenital malformations

Relationship between congenital anomalies and contraception

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

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