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Conjugated estrogens / medroxyprogesterone Pregnancy and Breastfeeding Warnings

Conjugated estrogens / medroxyprogesterone is also known as: Premphase, Premphase 14/14, Prempro

Conjugated estrogens / medroxyprogesterone Pregnancy Warnings

Specific categories of malformations associated with conjugated estrogens use include cardiovascular defects, hypospadias, eye and ear malformations, and Down syndrome. In the Collaborative Perinatal Project involving 50,282 pregnancies, 866 first trimester exposures to progestational agents were documented. Of these, there were 130 exposures to medroxyprogesterone. The incidence of cardiovascular defects was significantly increased, with a standardized relative risk of 1.8. While not statistically significant, data also suggested an increased risk of hypospadias among offspring of women treated with progestational agents in the first trimester. In the Michigan Medicaid Birth Defects Study involving 229,101 pregnancies from 1985 to 1992, there were 327 first trimester exposures to medroxyprogesterone (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). Overall, 15 cases of birth defects were observed (13 cases expected). Seven cases of cardiovascular defects occurred compared with 3 cases expected, representing a significant increase in the incidence of cardiovascular defects. Of interest, in all seven cases, the indication for maternal treatment with medroxyprogesterone was amenorrhea and not threatened spontaneous abortion. No cases of hypospadias occurred. Other studies have failed to find an association between first trimester use of progestational agents and congenital anomalies, including cardiovascular and genitourinary defects. In addition, follow-up studies have concluded that the use of medroxyprogesterone during pregnancy does not affect the long-term growth and development of children. There are data which suggest an increase in the frequency of low birth weight among infants of accidental pregnancies during contraception with intramuscular medroxyprogesterone.

Conjugated estrogens-medroxyprogesterone has not been formally assigned to a pregnancy category by the FDA. Conjugated estrogens and medroxyprogesterone have been assigned to pregnancy Risk Factor X by Briggs et al. Animal studies have not been reported. There are no controlled data in human pregnancy. Conjugated estrogens-medroxyprogesterone is considered contraindicated during pregnancy.

Conjugated estrogens / medroxyprogesterone Breastfeeding Warnings

There are no data on the excretion of conjugated estrogens into human milk. However, a decrease in quality and quantity of milk is associated with the administration of estrogen to nursing women. The American Academy of Pediatrics considers estradiol, another estrogenic agent, to be compatible with breast-feeding. Medroxyprogesterone is excreted into breast milk. Lactation does not appear to be adversely affected by contraceptive use of medroxyprogesterone. The American Academy of Pediatrics considers the use of medroxyprogesterone to be compatible with breast-feeding. The manufacturer recommends that caution be used when administering conjugated estrogens-medroxyprogesterone to nursing women.

The excretion of medroxyprogesterone into breast milk was evaluated in 10 women who received medroxyprogesterone acetate 150 mg intramuscularly for contraception. Mean medroxyprogesterone milk concentrations ranged from approximately 8 ng/mL at one week to approximately 0.5 ng/mL at 12 weeks after the injection. The milk to maternal serum concentration ratio ranged from 0.12 to 2.60 (mean 0.88). Contraceptive use of medroxyprogesterone does not adversely affect the content or volume of breast milk. In addition, progestin during lactation may promote longer duration of lactation. Long-term follow-up studies of up to eight years duration have failed to document adverse development effects due to exposure to medroxyprogesterone in breast milk.

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