Risks & Guidelines for Prescribing Psychiatric Medications for Women of Childbearing Age…

Plan for the unplanned:

• Approximately 50% of the pregnancies in the US are unplanned.
• Routine counseling of ALL women, regardless of their plans to conceive, needs to be routine.
• Select medications with the least risk for any women of reproductive age.
• One recent national study showed that one-third of young women were using the “withdrawal method” as their primary form of birth control.
• 4% of them experienced an unwanted pregnancy.
• Psychiatrists need to actively integrate our patients’ desires for pregnancy into our treatment plans, while being selective in our use of medications.

Pregnancy has inherent risks:

• The rate of congenital malformations in the general population of the US is approximately 3%.
• Known risk factors for complications include:
  • Advanced maternal age (i.e being over age 35)
  • Smoking
  • Alcohol use
  • Uncontrolled diabetes
  • Obesity
• Decision making regarding treatments in pregnancy requires:
  • Considering what is known about the medication in pregnancy
  • The symptoms or disorder that is being treated
  • The risks to the baby of both untreated maternal illness versus the medication

The Centers for Disease Control recommends the following:

• Take folic acid ( four times the recommended dose if using an anticonvulsant).
• Maintain healthy diet and weight.
• Continue regular physical activity.
• Do not use tobacco, alcohol or drugs.
• Get regular check ups and manage any medical illnesses.

Treatment considerations when planning for pregnancy:

• The initial selection of a medication should include the data regarding what is known about its use in pregnancy, regardless of how much is known for the following reasons:
  • Switching medications during pregnancy will mean that a woman will have more than one exposure to a potential risky medication.
  • A trial of any new medication is complicated by the fact of the unknown risk to benefit ratio for the patient.

What are the known risks?

• For many medications, such as SSRIs, benzodiazepines and lamictal, there a large number of published studies, some with conflicting results. It is important to evaluate the source of the information and discuss it with your psychiatrist.
• Some medications are known to cause birth defects (Depakote, Tegretol, Lithium). However, it is important to consider the absolute risk in order to make an educated decision:
  1. With Lithium, the absolute risk of Ebstein’s anomaly, a known specific cardiovascular malformation, is 0.1% to 0.2% when there is exposure in the first trimester.
  2. With Depakote, known and common neural tube defects occur in 5% to 10% of the population.

FDA pregnancy categories (A,B,C,D,X):

• Are of limited use and can be misleading.
• Pharmaceutical companies are required to have only animal data, although some do have a small amount of human data (that is not required).
• Animal studies typically give over 10 times the equivalent of a human dose.
• No company has data regarding the effects in human pregnancy. In fact, women who are pregnant are now banned from participating in clinical trials for new medications and have been for several years.

The bottom line:

• FDA categories are misleading.
• A drug that is category “D”, despite being well studied, may have found to have a small and/or inconsistent risk whereas a newer agent may be labeled as a category “B” because it has never been studied in human pregnancies.
• Unfortunately, the FDA classifications rarely inform anyone how to select a medication that is safe in pregnancy.

Important guidelines:

• Psychotherapy should be the first choice for all women.
• When medication is necessary, select the medication that is most reasonable based on the individuals personal history and treatment response.
• Minimize the number of medications used.
• Arrange for careful monitoring of mood throughout the pregnancy and the postpartum period.
• Educate the patient about the importance of sleep once the baby is born.

NO MEDICATION IS EVER “SAFE”. THE RISKS OF UNTREATED DISORDERS MUST BE TAKEN INTO ACCOUNT IN TERMS OF BOTH INFANT AND FETAL EXPOSURE.

Please feel free to reach out to us with any questions or to schedule a consultation with Dr. Gray regarding your women’s health and needs.

Hear’s To A Healthy Pregnancy and Beyond,
Dr. Nicola Gray