The FDA recently approved a 7.5-mg formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate for the treatment of hot flashes. It will be marketed under the name of Brisdelle.
It is estimated that autism spectrum disorders (ASD) affect about 1% to 2% of children. Research carried out in twins and families indicate that ASD is highly heritable; however, it is generally believed that while genetic factors play an important role, there is an interplay between genetic and environmental factors in the etiology of this disorder. Various environmental exposures have been implicated, including vaccinations, mercury, air pollution, insecticides, and infection.
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.
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.
Over the last decade, attention in the medical literature has gathered logarithmically to focus on potentially efficacious treatments for perinatal depression. Studies of relevant databases, editorials, and various reviews have addressed the reproductive safety concerns of antidepressant treatments, particularly selective serotonin reuptake inhibitors (SSRIs) on one hand, and the impact of untreated maternal psychiatric illness on fetal and maternal well-being on the other.
Prozac hit the market in 1988, the first selective serotonin reuptake inhibitor (SSRI) antidepressant approved by the FDA for the treatment of depression. Because it was safer and more tolerable than the antidepressants that preceded it, Prozac was soon the most commonly prescribed antidepressant in the United States.
Multiple studies have demonstrated an increased risk of poor neonatal adaptation associated with exposure to selective serotonin reuptake inhibitor (SSRI) antidepressants in late pregnancy. Results in the literature consistently indicate that about 25%-30% of infants exposed to SSRIs late in pregnancy manifest symptoms of poor neonatal adaption, including jitteriness, restlessness, increased muscle tone, rapid breathing. These symptoms are transient, resolving spontaneously with no specific medical intervention.
Escitalopram, when used in the treatment of menopausal vasomotor symptoms, did not worsen overall sexual function among non-depressed midlife women.
A few weeks after the FDA called into question the association between SSRI exposure and persistent pulmonary hypertension of the newborn or PPHN, BMJ published another article supporting an increased risk of PPHN among infants exposed to SSRIs in utero.
In 2006, Chambers and colleagues published an article in the New England Journal of Medicine linking SSRI use during late pregnancy to an increased risk of persistent pulmonary hypertension in the newborn (PPHN). Based on these findings, the “Usage in Pregnancy” section on the labels for SRRI antidepressants was updated to include the following warning: “Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN).”
