Possible Zoloft-bound Birth Defects to be Watched out
by Pregnant Women
Zoloft (generic name: setraline)
is an antidepressant drug
manufactured by the
pharmaceutical company Pfizer.
According to media reports,
when Zoloft was released in the
global market, it instantly
became one of the biggest-
selling antidepressant drugs..
However, some patients who
are taking antidepressants like
Zoloft get no medical benefits
from the drug compared to placebos. Numerous medical professionals and researchers have been
consistently reporting various Zoloft side effects.
A major severe Zoloft side effect was recognized in cases in which several pregnant women were given
this drug during the first trimester of pregnancy; the newborn babies ended up with congenital birth
injuries and their moms had withdrawal symptoms that remained for days, weeks or even years after
The studies have concluded that Zoloft causes a wide range of birth defects specifically cardiac
malformations, such as atrial septal defects and ventricular septal defects. These usually happen when
the mother took Zoloft during the first trimester of pregnancy, during which the baby’s heart was still
developing in the womb. Another severe side effect is persistent pulmonary hypertension of the
Newborn (PPHN), which is equivalent to high blood pressure in babies’ lungs. PPHN can be
tremendously serious and it may lead to death in extreme cases. Craniosynostosis (skull deformation)
and limb abnormalities are also other birth injuries that are attributed to Zoloft. These defects can be
dangerous. Certain defects can correct themselves while others cannot and may even lead to
complications and surgeries. It was also known that newborns may also have low blood sugar and
experience difficulty in breathing, vomiting, seizures, tremor and irritability.
The US Food and Drug Administration (FDA) released a public health advisory that says:
“FDA is advising health care professionals to discuss the potential risk of birth defects with patients
taking antidepressants that plan to become pregnant or are in their first three months of pregnancy.
Health care professionals should consider discontinuing antidepressant intake (and switching to another
antidepressant if indicated) in these patients. In some patients, the benefits of continuing
antidepressants may be greater than the potential risk to the fetus. The FDA is advising health care
professionals not to prescribe antidepressants in women who are in the first three months of pregnancy
or are planning pregnancy, unless other treatment options are not appropriate.”
Due to the above-stated birth defects, Pfizer was ordered by the FDA to change the pregnancy category
of Zoloft from C to D. The meaning of the D category is that studies conducted in pregnant women had
presented proof that the drug puts the fetus at stake. Medical professionals said that it important to
properly verify the type and timing of the medications prescribed for pregnant women as well as those
who are planning to get pregnant soon. Pfizer has been already charged with Zoloft lawsuit by the
affected patients for the damages caused by the drug.