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Zofran Birth Defect – Craniofacial Defects

Craniofacial defects are defects in the structure or function of an infant’s face and head present at birth. The anti-nausea drug ondansetron (Zofran) has been frequently prescribed for morning sickness in pregnant women during their first trimester, although it has not been approved by FDA for use during pregnancy. Recent research has linked the use of this drug during early pregnancy to two craniofacial defects: cleft palate and cleft lip.

If you took Zofran in your first trimester of pregnancy and your baby was born with craniofacial defects, contact our Zofran attorneys right away. You may have a claim for compensation for the losses and challenges you and your family are facing.

Our practice at Farah & Farah is devoted to representing people who have been harmed by dangerous drugs and devices. We are investigating cases nationwide involving craniofacial and other birth defects caused by Zofran. When you work with our firm, you can rest assured that we will fight relentlessly for the compensation you deserve. Call today at (800) 533-3555.

Craniofacial Defects Linked to Zofran

A study published by the National Institutes of Health (NIH) reports that in a recent large case study, researchers found a twofold increased risk of cleft palate with Zofran taken for morning sickness during the first trimester of pregnancy. A different study published by NIH also found possible risks of cleft lip and cleft palate associated with treatment with Zofran.

Cleft palate is an opening or split in the roof of the mouth or palate. Cleft lip is a split or opening in the upper lip. These conditions occur when facial structures developing in the fetus fail to close completely. Most cases of cleft lip and cleft palate will require a series of surgeries to restore normal function and appearance.

The Centers for Disease Control and Prevention (CDC) reports that a baby’s lips form between the fourth and seventh weeks of pregnancy, and the palate forms between the sixth and ninth weeks. According to NIH, morning sickness usually begins in the first month of pregnancy and continues through the third or fourth month. Based on this timing, Zofran prescribed for morning sickness would likely be taken during the period when the lips and palate of the fetus were in the formative stages.

Zofran Passes through the Placenta to the Fetus

The American Society for Clinical Pharmacology and Therapeutics conducted a study, published by the National Center for Biotechnology Information (NCBI) in 2014. Researchers found that Zofran passes rapidly through the placenta, and when this drug is taken by the mother, substantial amounts of the drug are passed to the fetus. The study also determined that Zofran has a longer elimination half-life, which means that the drug remains active longer in the fetus than in the mother. As Zofran taken in early pregnancy has been linked to craniofacial and other birth defects, the rapid transfer of this drug through the placenta presents great risk for an unborn child.

Multi-District Litigation Against Zofran Manufacturer

Twelve different lawsuits by parents whose children were born with birth defects were filed against Zofran manufacturer, GlaxoSmithKline. These cases were consolidated in multidistrict legislation (MDL) in the U.S. District Court, District of Massachusetts before Judge Dennis F. Saylor IV on October 12, 2015. Numerous cases of Zofran-related birth defects have been added to this MDL since that time.

As stated in an article on Law 360, parents suing GlaxoSmithKline as part of the MDL have reason to believe that the company has evidence regarding the link between Zofran and birth defects, such as animal studies conducted in Japan. In January of 2016, Judge Saylor denied GlaxoSmithKline’s motion to dismiss claims alleging that the company’s off-label promotion of Zofran for morning sickness led to birth defects.

What Can You Do If Your Child Was Born with a Craniofacial Defect Caused by Zofran?

According to the Mayo Clinic, most babies with cleft lip or cleft palate can be restored to normal function and appearance with minimal scarring, but it will take repeated surgeries to accomplish. If your child’s condition was caused by a dangerous drug that you took on the advice of your doctor during the term of your pregnancy, you may be entitled to claim compensation for the damages you have suffered, including funds to pay for current and future medical expenses, lost wages, and other damages.

Our Zofran birth defect lawyers at Farah & Farah are knowledgeable, compassionate, and tenacious. Fighting big pharmaceutical companies on behalf of our clients is what we do. Contact our office immediately so we can discuss the specifics of your case. We offer a free initial consultation. When you work with our firm, you pay us no fees until we recover compensation for you.


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Who We Are

The pharmaceutical litigation attorneys at Farah & Farah go after negligent corporations that put unsuspecting consumers in harm's way. Pharmaceutical companies not only have a duty to manufacture drugs that are safe, but they also have the obligation to warn consumers regarding dangerous side effects that can be caused by these drugs.

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