David Baxter PhD
Late Founder
Weighing the Risks of Using Psychiatric Drugs During Pregnancy
By Candida Fink MD
July 9, 2010
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:
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.
Category | Risk
A | Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm appears remote.
B | Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).
C | Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
D | There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
X | Studies in animals or human beings have demonstrated fetal abnormalities, or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Psychiatric medications have a very limited database concerning use in pregnancy. We know that certain psychotropic medications carry a higher risk than others:
For more about managing bipolar during pregnancy, see my previous Q&A post: ?How can I best manage bipolar during pregnancy??
By Candida Fink MD
July 9, 2010
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.
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.
A | Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm appears remote.
B | Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).
C | Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
D | There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
X | Studies in animals or human beings have demonstrated fetal abnormalities, or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
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.
For more about managing bipolar during pregnancy, see my previous Q&A post: ?How can I best manage bipolar during pregnancy??
