Medroxyprogesterone Pregnancy and Breastfeeding Warnings
Medroxyprogesterone Pregnancy Warnings
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 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.
Medroxyprogesterone has been assigned to pregnancy category X by the FDA.. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Medroxyprogesterone is considered contraindicated during pregnancy.
Medroxyprogesterone Breastfeeding Warnings
Medroxyprogesterone is excreted into breast milk. Lactation does not appear to be adversely affected by contraceptive use of medroxyprogesterone. Medroxyprogesterone is considered compatible with breast-feeding by the American Academy of Pediatrics.
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 use 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.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.