Congenital limb reduction deformities and use of oral contraceptives

Kricker, Anne; Elliott, Jane; Forrest, Jill M.; McCredie, Janet

doi:10.1016/0002-9378(86)90352-2

Cited by 36 publications

(19 citation statements)

References 12 publications

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“…In relation to neural tube defects, Kricker et al (1986) observed an association of 30.2 in the presence of history of OC use, possibly related to a recall bias.…”

Section: Evidence Of Association Between Oral Hormones and Orofacial mentioning

confidence: 92%

Chemical exposure during pregnancy and oral clefts in newborns

2002

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“…In relation to neural tube defects, Kricker et al (1986) observed an association of 30.2 in the presence of history of OC use, possibly related to a recall bias.…”

Section: Evidence Of Association Between Oral Hormones and Orofacial mentioning

confidence: 92%

Chemical exposure during pregnancy and oral clefts in newborns

2002

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“…In the 1980s 2 other epidemiological studies supported these findings (Hadjigeorgiou et al, 1984;Kricker et al, 1986). However, 2 articles published in the 1970s did not support an increased incidence of nongenital malformations in women exposed to sex steroids and/or progestational drugs (David and O'Callaghan, 1974;Nocke, 1978).…”

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

confidence: 63%

“…However, the concordance of the control and exposed groups for the other 19 reproductive parameters was statistically improbable and made the positive results problematic. Kricker et al (1986) duplicated many aspects of the Janerich et al (1974) study. Unfortunately, these investigators made many of the same errors that were present in the Janerich study.…”

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

confidence: 96%

“…In the 1980s, some studies concluded that there was an association between sex steroids and congenital heart disease (Hadjigeorgiou et al, 1984) and LRDs (Kricker et al, 1986). Hadjigeorgiou et al (1984) found an association between sex steroid exposure (estrogens and progestins) and congenital heart disease in a case-control study.…”

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

confidence: 97%

“…Just as in the Janerich study, all types of LRDs were included (unilateral, bilateral, congenital amputations, genetic LRDs, and others). Kricker et al (1986) were able to determine the exposure to the sex steroids more accurately. Eighteen of the malformed children had some type of OC exposure, but 10 of the exposures occurred during the first month of gestation.…”

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

confidence: 99%

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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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