Zofran is an FDA-approved prescription medication that is designed to treat and prevent post-surgery induced nausea and vomiting, and is manufactured by pharmaceutical giant GlaxoSmithKline. Zofran works by blocking the serotonin in the areas of the brain that trigger nausea and vomiting. It is primarily prescribed to patients undergoing chemotherapy and radiotherapy. Common side effects associated with Zofran usage include diarrhea, headache, fever, lightheadedness, dizziness, drowsiness, constipation, rash, blurred vision and muscle spasms.
In recent years, physicians have been prescribing Zofran to pregnant women with nausea and vomiting induced by morning sickness. Unfortunately women who thought Zofran was the solution to their morning sickness are not learning about its potential risks and serious side-effects until it is too late. Some of the more serious birth defects associated with Zofran use include cleft lip and cleft palate, heart complications, kidney complications, musculoskeletal defects, poor fetal growth and fetal death.
Studies Show Risk of Birth Defects from Zofran
Women have begun filing lawsuits against drug manufacturer GlaxoSmithKline claiming that their children suffered serious birth defects after they were prescribed Zofran. A majority of the plaintiffs have claimed their children suffered from congenital heart defects, cleft palate, or cleft lip.
In 2012, a group of researchers at Harvard University conducted a study on the potential birth defects and other adverse side effects that might result from pregnant women taking Zofran. This particular study found that the risk of cleft palate doubled after prenatal exposure to the drug. Additional follow-up studies have also suggested a link between Zofran and various heart defects in babies.
Zofran was initially approved by the Food and Drug Administration (FDA) for treatment of nausea and vomiting in patients who were undergoing chemotherapy treatment, radiation therapy, and those who might become nauseous after a surgical procedure. And while Zofran was never approved as a treatment for expecting mothers, it quickly became the leading treatment for morning sickness among pregnant women.
Did GlaxoSmithKline Hide Information from the FDA?
One of the key factors that will determine whether or not GlaxoSmithKline was negligent is whether or not the manufacturer withheld information regarding the risk of these birth defects from the FDA. Because the FDA’s decisions to approve drugs comes with a particular level of authority, lawsuits against drug manufacturers are sometimes dismissed if it is determined that the manufacturer or the FDA could not have been aware of the potential risks.
Conversely, if a drug manufacturer withheld pertinent risk information from the FDA that could have influenced the FDA’s decision to approve the drug for mainstream use, then the agency would not have been adequately able to evaluate the safety of the drug. Cases involving a drug manufacturer’s attempt to cover up risk of harm or injury often result in the manufacturer being held liable for the claimants’ damages.
If your child experienced serious birth defects after you were prescribed Zofran for morning sickness during pregnancy, you may be able to pursue a lawsuit against the manufacturer in order to recover the damages you have suffered. Davis Law Group will review your case for free to determine if we can help you with your claim. Use the contact form on this page or call (206) 727-4000 to get started.