Section 4.6

Psychotropic Drug Use during Pregnancy



Use of psychotropic medications during pregnancy is appropriate in many clinical situations and involves weighing the risk to the fetus of prenatal exposure to a medication versus risk to the patient or fetus of not using a medication.

Recommendations for use of psychotropics during pregnancy acknowledges increasing evidence that the absolute risk of congenital malformations following prenatal exposure to most psychotropics is low.

In addition to congenital malformations (teratogenicity), complications to fetus at birth, and complications to infant or child?s behavior patterns are also outcomes to evaluate in the risk assessment of prenatal exposure to all medications.

In 1993, the FDA published the Guidelines for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (found in the Federal Register) in order to establish some information about the effects of drugs in women. All medications are, or are suspected to be, excreted in breast milk. Affect on pregnancy is unique to women.

Since 1980, the FDA established five categories of safety for drug use in pregnancy (Federal Register 1980 44:37434-67). However, even when risk is established, these lettered categories do not fully delineate what the nature of the risk is. The nature of the risk is an important factor, as the potential risk is greater in different trimesters for different medications.

FDA?s Five Categories of Safety for Drug Use in Pregnancy - 1980

Category A: is defined as no fetal risks in controlled human studies. The only medication used in psychiatry in this class is thyroid hormone.

Category B: is defined either as no fetal risks in animal studies (but no controlled human studies) or positive fetal risk in animals (but no risk in well-controlled human studies). There are several medications used in psychiatry in this class including bupropion, fluoxetine, sertraline, buspirone, clozapine and possibly other antipsychotics.

Category C: is adverse fetal risks in animal studies and no data from well-controlled human studies. The majority of medications used in psychiatry are in this class.

Category D: is adverse fetal risks in humans. There are only a few medications used in psychiatry in this class, including benzodiazepines, lithium, and valproic acid.

Category X: is proven fetal risks in humans with no indication for use even in life threatening situations. There are no medications used in psychiatry in this class.

Discussion With Patient - Obtaining Consent

The decision to offer medications is based on a patient?s symptoms and impairment balanced with the risk of side effects and adverse effects that the patient and fetus might experience. If there are side effects, the patient may be able to tolerate the medication, a dosage change, or a medication change. However, the risk of adverse effects to the fetus are heightened because teratogenic side effects are irreversible (perinatal side effects such as sedation or "withdrawal" at birth are more manageable).

Even the most definite opinion and consent from the patient may be changed as the pregnancy progresses. This period of time is justification for more frequent monitoring by the psychiatrist and the care coordinator. A second opinion from another psychiatrist with documentation of the need and patient?s acceptance of the risk/benefit assessment may be considered.

Decision to Not Use Medications

The possibility of non-pharmacological treatment of symptoms may also need to be discussed with each patient. In many cases, the patient?s intention may be to try non-pharmacological management even if the severity of the mental illness would suggest there may be as much as a 50% chance of significantly impairing relapse. In these cases, it may be best to slowly taper medications rather than abruptly stopping medications with frequent monitoring. Ideally, this would happen before conception. The patient may need to be made aware of the possibility of worsening of symptoms to the extent that a more restrictive setting such as hospitalization is required. Almost in all cases, a strong recommendation can be made for restarting medications immediately after delivery due to the increased risk of symptoms worsening in the post-partum period. This would contraindicate breast feeding.

Decision to Use Medications

Psychotropic medications may be prescribed for pregnant women who have a diagnosis of a mental illness for which these medications are usually deemed beneficial if the expected benefit to patient and fetus clearly outweighs the potential risk to the fetus. It is possible that a different amount of medication may be needed during pregnancy. Checking drug levels early in pregnancy will provide a baseline for later when the patient? plasma volume will have expanded. It is possible that the patient may require 30% more of the medication to maintain the same blood level.

Examples of the expected benefit include treating severe symptoms associated with mental illness:

  1. Cause grave disability or impair patients ability to access minimum prenatal care,
  2. Cause violence to be directed at self (or fetus),
  3. Cause substance abuse that has greater risk for patient or harm to fetus,
  4. Cause a negative (or psychotic) maternal reaction to the pregnancy or fetus,
  5. Allow the individual to remain in her residence or otherwise avert hospitalization,
  6. Cause other exacerbations of the normal physical changes in pregnancy.

No Decision Was Made About Medications Before Pregnancy

If the patient becomes pregnant while on medications and the patient would not have chosen to take this risk, the discussion with the patient may consider stopping the medications, tapering the medications, continuing the medications and the possibility of a TAB.