While the absolute risk of birth defects remains small at 1 percent
to 3 percent across all pregnancies, researchers found that using
paroxetine during the first trimester was linked to a 23 percent
increase in risk for major congenital malformations and a 28 percent
higher risk of heart defects.
The study doesn’t prove that paroxetine causes birth defects, the
study team notes in the British Journal of Clinical Pharmacology,
but the analysis is important because the drug is widely prescribed
and as many as one fifth of women of child-bearing age may
experience symptoms of depression.
“In the majority of cases – mild to moderate depression –
psychotherapy and exercise regimens are valid treatment options,”
said lead study author Anick Berard of CHU Sainte-Justine and the
University of Montreal.
Left untreated, depression during pregnancy is associated with
underweight babies who are more likely to wind up in neonatal
intensive care, previous research has found. Pregnant women with
uncontrolled depression may not eat well or keep up with prenatal
visits, and, in the most severe cases they may be at increased risk
for suicide.
Like many drugs, antidepressants fall into a gray area during
pregnancy, with insufficient evidence to definitively prove the
harms or benefits. Often, doctors may reserve drugs for women with
more severe depression.
Paroxetine is in a family of medicines known as selective serotonin
reuptake inhibitors (SSRIs) that also includes drugs such as Prozac,
Zoloft and Celexa. Some SSRIs are generally considered a safe option
for pregnant women, but Paxil already carries a warning label
cautioning against use during pregnancy due to the potential for
fetal heart defects.
To assess the connection between Paxil and birth defects, Berard and
colleagues did a fresh analysis of data from 23 studies published
from 1966 to 2015. The individual studies included anywhere from 500
subjects to more than 800,000.
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Because the number of defects found in some studies was small, more
research is still needed to confirm the findings, the authors
caution. The analysis also lacked data on the severity of maternal
depression, and it’s possible that women who took medications for
the condition had other health problems that might contribute to an
increased risk for birth defects.
“As the authors themselves point out, depression during pregnancy is
itself a risk factor for smoking, alcohol and substance use, and
poorer nutrition – all of which may increase the risk for congenital
malformations,” said Dr. Roy Perlis, a psychiatry researcher at
Harvard University and Massachusetts General Hospital in Boston who
wasn’t involved in the study.
Two recent, large studies of SSRIs that weren’t included in the
current analysis also suggest a risk with Paxil but not the other
drugs in this family of medicines, Perlis added by email.
“We have multiple good treatment options for depression – including
medications and certain kinds of talk therapy,” Perlis said. “For
women who do need medication treatment, there are multiple
alternatives to paroxetine.”
SOURCE: http://bit.ly/1Oip8Lc British Journal of Clinical
Pharmacology, online January 7, 2016.
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