All women and men of reproductive age will achieve optimal health and wellness, fostering a healthy life course for them and any children they may have.Background
- Approximately 10% to 15% of congenital anomalies in the U.S. are attributed to prescription medication use by the pregnant woman (Dunlop et al., 2008).
- Over the last three decades, the use of prescription medications in the earliest weeks of pregnancy has increased by more than 60%. (Mitchell et al., 2011).
- In 2008, 50% of women reported taking at least one prescription medication in the first trimester and 7.5% reported taking 4 or more (Mitchell et al., 2011).
- Another report covering the years 2006-2008 found over 80% of women reported taking at least one prescription or over-the-counter medicine in the first trimester (Thorpe, et al, 2013).
- National surveys estimate that 18-52% of the U.S. population, including a substantial proportion of women of childbearing use, uses dietary supplements including vitamins, herbs, folk remedies, weight loss aids and sport enhancement substances (Gardiner et al., 2008).
- Clinical trials for approval of a new drug by the Food and Drug Administration (FDA) generally exclude pregnant women; trials generally include monitoring of reproductive performance in animals but the findings may not reflect the impact on human embryos and fetuses.
- There is insufficient data available to fully understand the fetal risk for medications commonly used during pregnancy (Thorpe et al., 2013).
- Prescription medications are assigned an FDA pregnancy category, but the categories offer limited and imprecise guidance placing clinicians at a disadvantage in their efforts to provide clear and accurate information to women who are or may become pregnant.
- Dietary supplements and herbal remedies are not regulated in the same way as prescription medications so even less reliable safety information is available for these products.
- Various resources are available to assist clinicians in their assessments of drug safety: see Clinical Resources. Of particular usefulness is the resource provided by the Organization of Teratology Information Specialists (OTIS) which provides information for women in both English and Spanish. This content can be reached at http://www.mothertobaby.org/otis-fact-sheets-s13037 .
- Congenital anomalies caused by teratogenic exposures, such as certain medications, are considered preventable because they are linked to avoidable exposures during the period of organogenesis.
- Because the period of organogenesis begins 3 days after the first missed menstrual period, efforts to reduce avoidable exposures must be initiated before the woman becomes pregnant.
Preconception strategies for minimizing exposure to potentially teratogenic medications in early pregnancy start with (Dunlop et al, 2008):
- Identification of the specific exposures and patterns of use for:
- Prescription medications
- Over-the-counter medications
- Dietary supplements
- Folk and herbal remedies
- Assessing the likelihood a woman is or will become pregnant while taking any of these drugs, supplements and remedies.
- A challenge for health care providers is to choose the most appropriate medication for treating a woman’s acute or chronic diseases given her desires and likelihood of conception.
- Before prescribing or refilling any medication, determine a woman’s likelihood of pregnancy while exposed to a medication:
- Woman wants to become pregnant in near future and not using contraception:
- If being treated for a chronic disease , switch medications to safest known treatments prior to conception (this is likely to be a process and may take some time to find the best and safest treatment regimens).
- Advise of potential risks of any medications she currently takes;
- Counsel to avoid non-essential medications;
- Counsel to use a hormonal method of contraception consistently, avoid intercourse or use a barrier method of contraception while on the potentially risky medication;
- Educate about Plan B in case unprotected intercourse occurs;
- Educate the woman that she should NEVER discontinue treatments for chronic disease without clinical guidance even if she discovers she has become pregnant.
- Woman does not want to become pregnant but having heterosexual intercourse with no, inconsistent or user-dependent methods of contraception.
- Because the woman is at risk of an unintended pregnancy, switch medications to safest known treatments (this is likely to be a process and may take some time to find the best and safest treatment regimens).
- Advise of specific and potential risks of any medications she currently takes;
- Encourage to start and consistently use a hormonal method of contraception until desires to become pregnant;
- In meantime, she should avoid intercourse or use a barrier method of contraception while on potentially risky medication;
- Educate about Plan B in case unprotected intercourse occurs;
- Educate the woman that she should NEVER discontinue treatments for chronic disease without clinical guidance even if she discovers she has become pregnant.
- Woman wants to become pregnant in near future and not using contraception:
- If possible, women at risk of pregnancy should not be prescribed medications known or suspected to be harmful to the embryo. Some common medications contraindicated in pregnancy are (Dunlop, et al., 2008):
- Angiotensin-converting enzyme (ACE) inhibitors and angiotension II receptor blockers
- Statins
- Anticonvulsants including
- Carbamazepine
- Phenytoin
- Valproic acid
- Warfarin derivatives
- Folic acid antagonists
- Antibiotics including
- Streptomycin
- Kanamycin
- Tetracycline
- Isotretinoin (Accutane ™ )
- Thalidomide
- Lithium
- If a woman at risk of pregnancy is already on one of these medications consider changing the therapeutic regimen to a less risky choice.
- Limit use of essential medications to the smallest number of drugs at the lowest effective doses to manage chronic and acute needs.
- In general, it is unwise to prescribe newer drugs to women of reproductive potential because the full effects of the drug on human reproduction may not yet have been revealed.
- Every woman who could become pregnant while using a prescription or over-the-counter medication or herbal therapy should be aware of the importance of avoiding unnecessary exposures in the earliest weeks of pregnancy.
- Women should be reassured that taking one multivitamin daily is without danger and offers protections against some birth defects; however, taking multiple vitamins may create nutritional imbalances which have the potential to cause problems for her and for future pregnancies.
- Women should be advised that herbal products and supplements are not regulated in the same way as prescription drugs making it impossible to assure the quality of the products and to assess their impact before or during pregnancy.
- Some over-the-counter medications also carry risks in and around pregnancy; the safest choice is to avoid these remedies if a woman could become pregnant.
- Every mother and fetus is different; therefore, it is impossible to say any drug will endanger all fetuses or will never endanger any fetus. The safest choice is to avoid those exposures that can be avoided safely if pregnancy is desired or a possibility.
- A pregnancy is at greatest risk for adverse consequences of medication use during the earliest weeks of pregnancy (often before the woman even knows she is pregnant); therefore, all women who use a prescription medication should work with their providers to find the safest treatments for chronic diseases before becoming pregnant.
- A woman should NEVER discontinue treatment for a chronic disease without clinical guidance even if she thinks she has become pregnant.
Clinical Guidance
- Identify specific exposures and patterns of use for:
- Prescription medications
- Over-the-counter medications
- Dietary supplements
- Folk and herbal remedies
- Acknowledge that you hear that she does not want to become pregnant in the next year.
- Encourage her to contact your office if her desires to become pregnant change prior to her next routine visit.
- Provide education about the wisdom of working with your practice and her other providers prior to stopping her method(s) of contraception, when she does desire a pregnancy, to minimize exposure of an embryo to non-essential medications and treatments in the earliest weeks of pregnancy.
- Emphasize that she should NEVER discontinue medication regimens for chronic diseases without clinical guidance even if she discovers she has become pregnant.
- Educate the women about strategies to minimize medication-related risks in future pregnancies by:
- Planning when to become pregnant;
- Avoiding non-essential medications (including over-the-counter, herbal and dietary supplements) whenever having intercourse and not using a highly effective method of contraception;
- Switching, under a clinician’s guidance, to the safest drug treatments for chronic conditions;
- Always volunteering any risks for becoming pregnant (e.g. using no contraception, using contraception inconsistently) whenever a medication is being recommended or prescribed.
- Emphasize that one multivitamin daily is highly recommended for her own health and the health of any future pregnancies but that more supplements are unnecessary and may pose some risks.
Clinical Tools
Treating for Two is CDC’s strategy to improve what we know about the safety of medication use in pregnancy and reduce harmful medication exposures. CDC is working with other federal agencies and non-federal partners to improve the quality and availability of information on the effects of medication use during pregnancy. This initiative will prevent birth defects and make mothers healthier by identifying the best treatments for managing health conditions during pregnancy and the childbearing years.
DART provides more than 200,000 journals references covering teratology and other aspects of developmental and reproductive toxicology. DART is funded by the U.S. Environmental Protection Agency, the National Institute of Environmental Health Sciences, the National Center for Toxicological Research of the Food and Drug Administration, and the NLM. DART has references from the early 1900s to the present. New references are added weekly.
The LactMed database contains information on drugs and other chemicals to which breastfeeding mothers may be exposed. It includes information on the levels of such substances in breast milk and infant blood, and the possible adverse effects in the nursing infant. Suggested therapeutic alternatives to those drugs are provided, where appropriate. All data are derived from the scientific literature and fully referenced. A peer review panel reviews the data to assure scientific validity and currency. LactMed is updated monthly.
OTIS: Fact sheets on common medications (in English and Spanish!) (Last updated 03/2013)
http://www.mothertobaby.org/otis-fact-sheets-s13037
Reprotox Information System for Exposures during Pregnancy (Paid Service) (Last updated 2013)
http://www.reprotox.org/Default.aspx
The InfantRisk Center from Texas Tech University Health Sciences Center is dedicated to providing up-to-date evidence-based information on the use of medications during pregnancy and breastfeeding.
Infant Risk Health Care Mobile App for Health Care Professionals: Medication Safety during Pregnancy (Paid Service)
http://www.infantrisk.com/mobile/infantrisk-hcp
Patient Resources
Treating for Two is CDC’s strategy to improve what we know about the safety of medication use in pregnancy and reduce harmful medication exposures. CDC is working with other federal agencies and non-federal partners to improve the quality and availability of information on the effects of medication use during pregnancy. This initiative will prevent birth defects and make mothers healthier by identifying the best treatments for managing health conditions during pregnancy and the childbearing years.
DART provides more than 200,000 journals references covering teratology and other aspects of developmental and reproductive toxicology. DART is funded by the U.S. Environmental Protection Agency, the National Institute of Environmental Health Sciences, the National Center for Toxicological Research of the Food and Drug Administration, and the NLM. DART has references from the early 1900s to the present. New references are added weekly.
The LactMed database contains information on drugs and other chemicals to which breastfeeding mothers may be exposed. It includes information on the levels of such substances in breast milk and infant blood, and the possible adverse effects in the nursing infant. Suggested therapeutic alternatives to those drugs are provided, where appropriate. All data are derived from the scientific literature and fully referenced. A peer review panel reviews the data to assure scientific validity and currency. LactMed is updated monthly.
The InfantRisk Center from Texas Tech University Health Sciences Center is dedicated to providing up-to-date evidence-based information on the use of medications during pregnancy and breastfeeding.
Mommy Meds from Texas Tech University Health Sciences Center http://mommymeds.com/
OTIS: Fact sheets on common medications (in English and Spanish!) (Last updated 03/2013) http://www.mothertobaby.org/otis-fact-sheets-s13037
References
American College of Obstetricians and Gynecologists (2007). Guidelines for Women’s Health Care: A Resource Manual (3rd ed). Washington, DC: ACOG.
American Academy of Pediatrics and American College of Obstetricians and Gynecologists (2013). Guidelines for Perinatal Care (7th ed.), AAP/ACOG: Evansville, Ill.
Cragan J. et al., (2006) Ensuring the safe and effective use of medications during pregnancy: planning and prevention through preconception care. Maternal Child Health Journal. 10(Suppl 1): 129-135.
Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1592140/ .
Dunlop, A.L., et.al. (2008). The clinical content of preconception care: the use of medications and supplements among women of reproductive age. American Journal of Obstetrics & Gynecology, 199 (6B): 367-372.
Thorpe PG., et. al. (2013). Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk. Pharmacoepidemiology and Drug Safety, 22, 1013-1018.
United States Medical Eligibility Criteria (USMEC) for Contraceptive Use. Centers for Disease Control and Prevention.
Available at: http://www.cdc.gov/reproductivehealth/unintendedpregnancy/usmec.htm
