Zofran Causes Multiple Birth Defects

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As of now over 282 lawsuits against Zofran manufacturer has been filed against the multi-national healthcare giant GlaxoSmithKline and consolidated in the Boston federal court for pre-trial proceedings. Women from all over the nation have filed lawsuits alleging their babies developed birth defects after being exposed to Zofran (known generically as ondansetron). Parents claim that during early pregnancy Ondansetron can cause severe Congenital Malformations on the fetus.. The FDA approved Zofran in 1991 as a drug to treat nausea and vomiting, but only in patients who have undergone chemotherapy or radiotherapy, or who are experiencing nausea after surgery. The medication has never been approved for the treatment of morning sickness in pregnant women. However, doctors are still prescribing Zofran to pregnant women as “off-label because they believe the chances of birth defects is rare.

In several lawsuits the women claims that Zofran medication forced them to terminate their pregnancy due to the severe physical malformations of their unborn child. There are several studies which clarify that Zofran exposure in pregnancy cause life-threatening birth defects. Zofran can lead to newborns having cleft palate, cardiac malformations and kidney malfunctions. As per Danish researchers Zofran active ingredient, a chemical known as ondansetron could boost the risk for cardiac septal defects by 200% to 400%. The Fertility Centers of New England warns women not to take Zofran during pregnancy. As per a register based nationwide cohort study, Ondansetron medications have adverse effects on the fetus during early pregnancy which causes “Congenital Malformations”. The severe birth defects caused by Zofran may include:

Cleft Palate

Cleft palate is a facial and oral malformation, is a gap in the roof of the mouth. Normally, the tissues that make up the lip and palate fuse together in the second and third months of pregnancy, while the baby is developing inside the mother. A cleft palate is an opening of the hard palate (the bony front portion of the roof of the mouth) or the soft palate (the muscular non-bony region in the rear of the roof of the mouth.

Cleft lip

A cleft lip contains an opening in the upper lip that may extend into the nose as well as gums. This can affect one side of the mouth (unilateral) or both sides (bilateral), and can be complete (meaning the cleft goes up into the nose) or incomplete.

Kidney Malfunctions

Kidney Malfunctions is also called as Kidney failure or end-stage renal disease (ESRD). It is the last stage of chronic kidney disease when kidneys fail and stop working.

Atrial Septal Defect

An atrial septal defect, or ASD, is a congenital (present at birth) abnormality characterized by a hole in the upper 2 chambers of the heart (atria). An abnormal formation of the inter atrial septum may result in a hole, or atrial septal defect.

Due to the increasing number of adverse events causes by Zofran intake during pregnancy the drug has been given an FDA rating of “Pregnancy Category B. Zofran lawsuit accuses GSK of promoting Zofran to pregnant women without receiving approval from the FDA and without conducting “a single clinical trial” in pregnant women.  In addition, GlaxoSmithKline not only marketed Zofran as a safe way to treat morning sickness, but the company also falsified animal studies on the drug, stating that it was safe despite the results showing that it can cause unusual bone growth and toxic illness.

Acquiring compensation from the Zofran class-action lawsuit isn’t as important to any mother as revealing the dangerous consequence of the drug to the Public. The manufacturers refused to warn users about the harmful side effects of Zofran. GSK presented false evidence about animal studies that showed Zofran medication is safe during pregnancy. If you or someone you know took Zofran and had a baby born with cleft palate, cardiac malformations, kidney malfunctions and other severe Congenital Malformations, please contact for a free case review. Our experience attorney’s team are dedicated to protecting consumers through individual litigation, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.

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