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Zofran, or ondansetron, is an anti-nausea medication primarily used to treat nausea in patients following chemotherapy treatments or surgical procedures. However, it has also been prescribed to pregnant women as a treatment to alleviate morning sickness. Zofran use by pregnant women has been indicated to result in birth defects, despite manufacturers’ statements that its use was safe for expectant mothers. The product liability attorneys at the Naumes Law Group are dedicating to assisting women who were reliant on these statements with pursuing legal action on behalf of their children and them. Our Boston Zofran lawyers take these reports of birth-related side effects seriously, and we are committed to making sure that the proper parties are held accountable for dangerous products that are released. We offer personalized legal representation and guidance, tailored to each of our clients’ needs. If you are a mother who has taken Zofran while pregnant, and you believe that your child’s condition is related to your use, we can help you determine whether legal action may be appropriate.

Studies Linking Zofran and Birth Defects

Zofran was approved by the Federal Drug Administration (FDA) in 1991 in order to treat vomiting and nausea for chemotherapy and surgical patients. It later became a popular medication prescribed to soon-to-be mothers to curtail morning sickness, but that off-label use was never tested or approved by the FDA. Despite the lack of approval, Zofran’s manufacturer, GlaxoSmithKline (GSK), marketed the drug as a morning sickness remedy. Since its rise in popularity, some studies have been conducted, with mixed results, to determine Zofran’s effects on developing fetuses.

The FDA has released notices stating that Zofran may increase the risk of babies being born with abnormal heart rhythms, as well as a potentially fatal heart condition known as Torsades de Pointes. Ongoing research has indicated a potential link between Zofran and the following additional birth defects:

  • Restrictions to fetal growth rate
  • Cleft palates
  • Skeletal disorders
  • Kidney issues

Although there is conflicting evidence regarding the connection between Zofran and birth defects, most medical professionals agree that the medication should only be used as a last resort treatment for morning sickness.

Establishing Liability for Drug Side Effects

Drug manufacturers are required to warn consumers of any known dangers that their medications contain. Allegations against GSK state that it knew of Zofran’s potential to increase the risk of birth defects for expectant mothers, but it did not inform the government or health care companies and providers of that risk. Additionally, the Zofran attorneys at our Boston firm understand that it is alleged that GSK actively engaged in promoting off-label use without conducting the proper research and testing. In 2012, the U.S. Justice Department pursued action against GSK for promoting its medications, which included Zofran, for off-label use. Documents related to the proceedings alleged that GSK provided kickbacks to doctors who prescribed Zofran for morning sickness, as well as giving false information regarding the medication’s safety and efficiency. Eventually, a settlement of $3 billion was reached.

Mothers who have taken Zofran while pregnant and whose children were born with birth defects may be entitled to damages for medical expenses, both past and future, as well as pain and suffering. Because of the complicated nature of these proceedings, as well as the nuanced, sometimes conflicting evidence involved, it is important to seek the advice of an experienced attorney if you are considering legal action.

Consult a Knowledgeable Zofran Lawyer Based in Boston

If you think that your child’s birth defect may have resulted from a Zofran side effect, the injury lawyers at the Naumes Law Group can help you with your effort to make sure that the manufacturer is held responsible. Our firm serves victims in Springfield, Worcester, Waltham, Watertown, Hyannis, Malden, Medford, Taunton, Peabody, Braintree, Weymouth, Quincy, Pittsfield, and Plymouth, as well as other areas of Suffolk, Middlesex, Barnstable, Berkshire, Bristol, Essex, Franklin, Hampden, Hampshire, Norfolk, Plymouth, and Worcester Counties. Call our office toll-free at 844-826-8445, or locally at 618-227-8444, or contact us online to speak with a Boston Zofran attorney at no charge.