Zoloft warning label : Zoloft pregnancy side effects

Pfizer packages Zoloft with a warning label insert that includes information about Zoloft pregnancy side effects. The insert warns that use of Zoloft during pregnancy increases birth defects risks.

The most recents revisions to the Zoloft label information insert were approved by the FDA on August, 19, 2011. The following sections warn of risks of Zoloft use by pregnant women.

PRECAUTIONS

Pregnancy-Nonteratogenic Effects–Neonates exposed to ZOLOFT and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These findings are based on post marketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see WARNINGS).

Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 – 2 per 1,000 births in the general population and is associated with neonatal morbidity and mortality. Several recent epidemiologic studies suggest a positive statistical association between SSRI use (including DRUG) in pregnancy and PPHN. Other studies do not show a significant statistical association. Neonates exposed to an SSRI in utero may benefit from careful monitoring for signs of respiratory distress over the first 72 hours after delivery. PPHN is an uncommon event, and the possible risk of such an event occurring in association with SSRI use needs to be carefully weighed against the potential benefits of treating depression with an antidepressant during pregnancy and the risks of not treating it. This decision can only be made on a case by case basis.

When treating a pregnant woman with ZOLOFT during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment (see DOSAGE AND ADMINISTRATION). Physicians should note that in a prospective longitudinal study of 201 women with a history of major depression who were euthymic in the context of antidepressant therapy at the beginning of pregnancy, women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.

DOSAGE AND ADMINISTRATION

Treatment of Pregnant Women During the Third Trimester–Neonates exposed to ZOLOFT and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with ZOLOFT during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering ZOLOFT in the third trimester.

Zoloft currently is categorized as a FDA Pregnancy Category C drug. The pregnancy category of a medication reflects an assessment of the risk of fetal injury (birth defects risk) of the medication when used during pregnancy. According to FDA guidelines, Pregnancy Category C classification indicates that “Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”

Recent Zoloft studies, however, have found that use of the SSRI antidepressant during pregnancy can increase the risk of several serious birth defects including club foot, cleft lip and palate, brain and spinal defects, abdominal defects, lung defects, and heart defects by as much as 600%.

If you or a loved one gave birth to a child with birth defects after taking Zoloft during pregnancy, you may be entitled to recover substantial financial compensation. Time limits apply to filing a claim. Contact us today for a free and confidential consultation with a top Zoloft lawsuit attorney. We are available 24 hours a day to answer your questions.