I recently noticed an article on the Web entitled “Psychotropic drugs can cause birth defects.” The article reports that “Researchers at the University of Copenhagen (UC) have documented the serious side-effects that can be associated with these types of medications.”

The trouble with articles like this is that they often cause unnecessary anguish and can be counterproductive in managing a healthy pregnancy while effectively treating psychiatric conditions of the expectant mother.

The actual study, “Adverse drug reactions from psychotropic medicines in the pediatric population: analysis of reports to the Danish Medicines Agency over a decade,” is much broader than the alarmist title of the article – it focuses on adverse drug reactions in the pediatric population (ages up to 17 years old, not just infants).

If you look at the actual numbers from the report, you quickly see that the data fail to support such an alarming headline about the use of psychiatric medications during pregnancy:

• The study included 4,500 pediatric adverse drug reactions, including patients up to the age of 17 years.
• 429 of those 4,500 reactions were linked to psychotropic medications. That means over 90 percent were linked to other drugs (not identified in the article).
• 20 percent of the 429 reports of adverse drug reactions in the pediatric population were for children from birth up to 2 years of age.

Yes, pregnant women and women who are planning a pregnancy should be concerned, but drugs of any kind during pregnancy can affect a developing baby. The chemicals cross the placenta and enter the baby’s circulation. The types of effects on the fetus vary depending on the medicine itself and on when the medicine is ingested during the pregnancy.

Medicines used to treat bipolar disorder and other psychiatric illnesses vary in their impact in the pre-natal period. Unfortunately the database for most medicines – including psychiatric ones – is limited, because we can’t do randomized studies in humans. We rely on these types of studies done with animals. In humans we look retrospectively at patterns of pregnancy outcomes and medication uses.

The FDA uses a classification system to describe the level of risk of a medication during pregnancy, based on the data that are available. As you can see, there is a wide range and many areas are quite unclear. Many medicines fall into category B or C – meaning that animal studies showed some risks, but human studies showed no risk – or there are no available human studies one way or the other.

Psychiatric medications have a very limited database concerning use in pregnancy. We know that certain psychotropic medications carry a higher risk than others:

• Certain medications such as lithium and benzodiazepenes, Tegretol, and Depakote – have well established negative outcomes in pregnancy and are considered dangerous.
• Antipsychotics have shown mixed results, but the research suggests that there may be significant risks to the fetus.
• SSRI antidepressants have been associated with a withdrawal phenomenon in babies when mom’s take these medications during the third trimester of pregnancy. The symptoms can include breathing problems, jittery or irritable temperament, trouble feeding, and low blood sugar. These typically resolve without further difficulties. But the FDA recommends that doctors discuss the possibility of not using SSRI’s in the third trimester.

The decision about medications in pregnancy is very individualized and must be addressed with careful thinking and discussion between mom, her psychiatrist and usually the obstetrician,as well. The risks of untreated psychiatric illness in pregnancy are considerable as well, so they must be factored into the equation.

For more about managing bipolar during pregnancy, see my previous Q&A post: “How can I best manage bipolar during pregnancy?“

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From Psych Central's website:
PsychCentral (July 9, 2010)

Netty Wisbaum (July 9, 2010)

    Last reviewed: 9 Jul 2010