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Sunday, April 25, 2010

Response to comment, re: depo provera

Anonymous wrote:

"
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

6. Unexpected Pregnancies

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

  • Pardthaisong T, Gray RH, McDaniel EB, Chandacham A. Steroid contraceptive use and pregnancy outcome. Teratology. 1988; 38:51–58.
  • Pardthaisong T, Gray RH, McDaniel EB, Chandacham A. Steroid contraceptive use and pregnancy outcome. Teratology. 1988; 38:51–58.
  • 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.)


    5 comments:

    kortney said...

    I wasn't anonymous, but I guess I should be thanking my lucky stars that my babe is beautiful, healthy, has 10 fingers and toes, and was 7 lbs 1 oz (considering the doctor told me to expect a five pounder and that I myself am only 5'2" and was preoprego 110 lbs!!!) that is more than a healthy sized baby. She's now in the 110th percentile for height...

    Thank goodness ;)

    Robert said...

    Methinks Anonymous didn't expect you'd actually have references to back up your claims--how's that for causation. ;)

    AtYourCervix said...

    @NurseXY: Eh. I can find support for many, if not all, of the things I post. I am, after all, a graduate student with access to huge volumes of research and other information.

    Anonymous said...

    I am "Anon"-- and it was an honest question. I had complete trust that a reliable answer would be provided. So let's keep things chill, eh?

    Robert said...

    As you wish Anon, although your previous comment still has a "prove it" undertone when I read it.

    But I stand corrected.

    Regards--