Zoloft Labels to Include Pregnancy Risk

Our team of Zoloft lawyers report that Pfizer is currently in talks with the FDA to update the drugs’ labels to include the risk of heart defects in infants born to mothers took the drug during pregnancy. Pfizer is facing hundreds of birth defect lawsuits filed by women who took Zoloft while pregnant, assuming the drug was safe.

Zoloft’s new labels would state that there is an increased risk of congenital cardiac defects – and specifically septal defects – in women who took the drug during their first trimesters. Meanwhile, Pfizer is arguing in court that there is not enough research to suggest that taking Zoloft during pregnancy can lead to birth defects.

Zoloft (sertraline) is a selective serotonin reuptake inhibitor, or SSRI, antidepressant. Approved in 1991, it is one of the most-prescribed medications in the country, generating billions in revenue for Pfizer. In 2012, the Zoloft birth defect lawsuits were consolidated into multi-district litigation (MDL) in Pennsylvania.

MDLs streamline pretrial proceedings by joining similar cases into one action. Seven federal judges comprise the Judicial Panel on Multi-District Litigation, deciding which cases are consolidated. MDLs are meant to speed up complex cases that share similar details, like a common defendant, or injury. MDLs are common in resolving drug injury cases, air disaster litigation, and medical device lawsuits.

Research shows that infants exposed to Zoloft in the womb are at an increased risk of several types of abnormalities, such as:

  • Craniosynostosis
  • Heart defects
  • Spina Bifida
  • Club feet
  • Respiratory problems
  • Tetralogy of fallot (TOF)
  • Cleft lip and/or palate

Research also shows these infants are at higher risk of poor feeding habits, restlessness, and high-pitched crying.

Unfortunately, women prescribed to Zoloft may experience problems if they suddenly stop taking the drug. These risks must be weighed with the risks to the child. Untreated depression is a very serious, potentially life-threatening condition. Consult with your doctor before making the decision to stop any type of antidepressants.

Zoloft is just one of several SSRIs associated with birth defects. These dangerous drugs include: Paxil, Prozac, Celexa, Lexapro, Effexor, Luvox, Zyban, Wellbutrin, and several others. Visit our SSRI Antidepressants webpage for more information.

Our team of Zoloft attorneys is currently accepting cases of birth injury from this drug, and we will continue to update you on the pending MDL status. If you took Zoloft or any other SSRI during pregnancy and had a child with congenital defects, contact our firm for a free consultation. You and your child may be entitled to benefits for you medical bills, current and continued care, and emotional distress.

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