"I've never seen or heard of any data linking Depo failure to increased defects. Can you provide a study?"
I went directly to the official FDA prescribing information for Depo Provera (Medroxyprogesterone acetate injectable suspension).
I have highlighted some important information in blue, and have highlighted the studies/causation information in red.
For full info, see this link:
FDA Prescribing Information
To ensure that Medroxyprogesterone acetate injectable suspension is not administered inadvertently to a pregnant woman, the first injection must be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5 days postpartum if not breast-feeding, and if exclusively breast-feeding, ONLY at the sixth postpartum week. (See DOSAGE AND ADMINISTRATION.)
Neonates from unexpected pregnancies that occur 1 to 2 months after injection of Medroxyprogesterone acetate injectable suspension may be at an increased risk of low birth weight, which, in turn, is associated with an increased risk of neonatal death. The attributable risk is low because such pregnancies are uncommon.9,10
A significant increase in incidence of polysyndactyly and chromosomal anomalies was observed among infants of users of Medroxyprogesterone acetate injectable suspension, the former being most pronounced in women under 30 years of age. The unrelated nature of these defects, the lack of confirmation from other studies, the distant preconceptual exposure to Medroxyprogesterone acetate injectable suspension, and the chance effects due to multiple statistical comparisons, make a causal association unlikely.11
Neonates exposed to Medroxyprogesterone acetate in utero and followed to adolescence, showed no evidence of any adverse effects on their health including their physical, intellectual, sexual, or social development.
Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female fetuses. The risk of hypospadias (five to eight per 1,000 male births in the general population) may be approximately doubled with exposure to these drugs. There are insufficient data to quantify the risk to exposed female fetuses, but because some of these drugs induce mild virilization of the external genitalia of the female fetus and because of the increased association of hypospadias in the male fetus, it is prudent to avoid the use of these drugs during the first trimester of pregnancy.
To ensure that Medroxyprogesterone acetate injectable suspension is not administered inadvertently to a pregnant woman, it is important that the first injection be given only during the first 5 days after the onset of a normal menstrual period within 5 days postpartum if not breast-feeding and if breast-feeding, at the sixth week postpartum. (See DOSAGE AND ADMINISTRATION.)
Read more: http://www.drugs.com/pro/medroxyprogesterone.html#ixzz0m84ptDgO
Selected references from above:
#9: Gray RH, Pardthaisong T. In Utero exposure to steroid contraceptives and survival during infancy. Am J Epidemiol. 1991; 134:804–811.
#10: Pardthaisong T, Gray RH. In Utero exposure to steroid contraceptives and outcome of pregnancy. Am J Epidemiol. 1991; 134:795–803.
#11: Pardthaisong T, Gray RH, McDaniel EB, Chandacham A. Steroid contraceptive use and pregnancy outcome. Teratology. 1988; 38:51–58.
My thoughts:
Depo Provera is considered a Pregnancy Category X drug -- "studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits." Some of the pregnancy outcomes have a possible link (see above) for low birth weight, polysyndactyly, chromosomal anomalies and hypospadias.
Granted, it would be highly unethical for researchers to conduct a randomized controlled study of the effects of depo provera on the developing fetus. There are also very limited numbers of fetuses exposed to depo provera during pregnancy to conduct thorough retrospective studies on the effects of the drug on fetal growth and development.
All we have left are possible causations between depo provera and noted birth defects/anomalies seen with the ensuing pregnancies. We need to assume the worst: that the depo provera causes the anomalies, because to truly test whether it causes the defects is highly unethical. Would you volunteer to conceive on purpose while receiving depo provera? I certainly would not.
Hope this was the answer you were looking for anonymous.
