New FDA Pregnancy Category Labeling: Still Waiting…
This is a very nice article published by the College of Psychiatric and Neurologic Pharmacists discussing the limitations of the current FDA pregnancy category labeling system.
This is a very nice article published by the College of Psychiatric and Neurologic Pharmacists discussing the limitations of the current FDA pregnancy category labeling system.
Since their introduction in the 1990s, atypical (second-generation) antipsychotics have replaced typical (first generation) antipsychotics as the first-line treatment for schizophrenia and related psychotic disorders. These drugs are widely used by reproductive age women across many other disease states including bipolar disorder, major depression and anxiety disorders as either primary or adjunctive treatments.
Iodine is essential for thyroid hormone synthesis. We have known for a long time that severe iodine deficiency during pregnancy may affect the cognitive development of the unborn child. According to a recent Lancet study, even children born to women with mild-to-moderate iodine deficiency during pregnancy are at increased risk for lower IQ and reading ability (assessed at age 9). The most severe effects were observed among children born to women with severe deficiency (<50 mcg/g iodine:creatinine ratio).Â
There have been multiple recent reports indicating that the use of valproate during pregnancy may be associated with lower IQ, cognitive problems, and developmental delays in exposed children. This has prompted the FDA to issue a warning regarding the use of valproate-containing drugs, including Depakote and Depakene, during pregnancy:
Atypical antipsychotic medications are commonly used for the treatment of schizophrenia and bipolar disorder. Despite the increasing use of these medications in women of child-bearing age, there is still relatively little data regarding the reproductive safety and long-term neurodevelopmental effects of these medications. A recent study assessed the development of 76 infants with fetal exposure to atypical antipsychotics.
The omega-3 fatty acids, including eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA), have a broad range of health benefits and may be beneficial for the treatment of mood disorders.  Because during pregnancy omega-3 fatty acids are diverted to the developing fetus, some women may develop a deficiency of omega-3 fatty acids during pregnancy. Previous studies have shown that pregnant women with lower levels of DHA may be more vulnerable to depressive symptoms. Several small studies have attempted to use omega-3 fatty acids to treat perinatal depression but have yielded inconsistent findings. Â
Some studies have shown an association between in utero exposure to antidepressants and various pregnancy outcomes, including preterm delivery, low birth weight, and lower Apgar scores; however, these outcomes have also been observed in infants born to depressed mothers who are not taking medication. Thus, it has been difficult to determine if there is a causal relationship between antidepressant exposure and these negative pregnancy outcomes or if untreated maternal depression is itself responsible for these negative outcomes.Â
Last summer, we posted a blog about using folate to treat (and perhaps prevent) depression in women of childbearing age. Supporting that recommendation are the several reports indicating that people with lower folate levels are at higher risk of major depression or may experience more severe depressive symptoms. Other studies have indicated that in folate-deficient patients, antidepressants may be less effective or may take longer to take effect.
While some studies have shown an association between in utero exposure to antidepressants and various pregnancy outcomes, including preterm delivery, low birth weight, and lower Apgar scores, these outcomes have also been linked to untreated maternal depression. Thus, it has been difficult to determine if there is a causal relationship between antidepressant exposure and negative pregnancy outcomes or whether maternal depression is itself responsible for these negative outcomes.
A significant number of women experience anxiety symptoms during pregnancy, with about 8.5% of women meeting criteria for generalized anxiety disorder. Other anxiety disorders are less common.  The estimated prevalence of panic disorder during pregnancy is 1-2%.  The estimated prevalence of obsessive-compulsive disorder is 0.2-1.2%. While we use certain tools, including the Edinburgh Postnatal Depression Scale (EPDS) to screen for depression during pregnancy, what are the best tools for indentifying women with clinically significant anxiety symptoms?