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zofran-morning-sicknessA growing number of Zofran studies suggest a link between the morning sickness medication and an increased risk of birth defects.

The anti-nausea medication was initially approved by the U.S. Food and Drug Administration to help cancer patients undergoing chemotherapy. However, because Zofran is known to help with nausea many physicians began prescribing the medication “off label” to women to use during pregnancy for morning sickness relief.

About 1 million women in the U.S. take Zofran while pregnant each year; however, mounting research indicates fetal exposure to the anti nausea drug may cause severe birth defects.

Zofran Birth Defect Studies

Zofran has been subject of multiple studies over the years; here are just a sample of some of the research findings. 

In 2004, a Zofran study published in the medical journal BJOG: An International Journal of Obstetrics and Gynecology linked fetal exposure to Zofran to an increased risk of hypospadias, which is a congenital condition in boys involving the opening of the urethra which is on the underside of the penis.

In 2011 and 2012, two separate Zofran studies concluded that taking Zofran while pregnant increased the risk of having a child born with a cleft lip or cleft palate by 2.4-fold.

In a 2013 study of 900,000 Danish women, researchers determined that Zofran use during pregnancy doubled the risk of having a child born with a heart defect and increased the chance of overall congenital malformations by 30 percent.

In 2014, a study published in the journal Reproductive Toxicology researchers found that women who exposed their unborn child to Zofran within the first trimester of pregnancy doubled the risk of having a child born with a “hole in the heart” defect. The Zofran study also indicated that the overall risk of heart birth defects due to fetal exposure of the medication increased by 62 percent.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Zofran’s Most Common Birth Defects

A recent release of all of the Zofran adverse event reports by the FDA showed hundreds of cases where the medication was named as the suspected cause of birth defects. The majority of the 475 Zofran birth defect cases reported congenital heart defects.

Some of the other consumer reported Zofran birth defects include:

  • Musculoskeletal defects
  • Fetal growth restriction
  • Spina Bifida
  • Congenital heart defects
  • Heart murmurs
  • Atrial septal defects
  • Ventricular septal defects
  • Kidney defects
  • Congenital diaphragmatic anomaly
  • Intrauterine death
  • Stillbirth

The U.S. Food and Drug Administration labels Zofran as a pregnancy category B drug, which means it is not expected to harm an unborn child. Despite numerous research findings and consumer reports, Zofran continues to be prescribed to one million expectant mothers each year.

Zofran Birth Defects Lawsuits

Nearly 80 percent of pregnant women report experiencing morning sickness symptoms and are often prescribed Zofran to alleviate nausea. However, those filing Zofran lawsuits claim they were not warned that the anti nausea medication might place their unborn child at risk for birth defects.

Many times, Zofran birth defect lawsuits are filed by parents on behalf of their children. Parents seek financial compensation to help cover the continuous medical treatments required to manage their child’s medical condition. Zofran lawsuits generally allege that drug manufacturer GlaxoSmithKline should have conducted clinical trials before marketing Zofran to pregnant women for morning sickness relief.

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The birth defect attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual Zofran lawsuit or Zofran class action lawsuit is best for you. [In general, Zofran lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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Get Help – It’s Free

Join a Free Zofran Birth Defects Class Action Lawsuit Investigation

If you or someone you know took Zofran while pregnant and had a baby with a birth defect, you or this person may have a legal claim. See if you qualify by filling out the short form below.

A Zofran birth defect attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

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