By Victoria Ipri – Staff Writer
Were you prescribed Zofran for nausea and vomiting while pregnant, then gave birth to a child with physical abnormalities? A January 2012 study from the Center for Birth Defects Research and Prevention reveals twice as many birth defects were caused by Zofran given during the first trimester, including cleft palate and some heart defects.
Due to the growing body of evidence, Zofran lawsuits have been initiated, alleging the manufacturer of Zofran was aware of this severe side effect, but failed to inform the government and healthcare providers. Further, the suits allege that additional testing and research was needed prior to marketing the drug, which would have allowed patients to make alternative treatment choices.
If you or a woman you care about took Zofran during pregnancy, these questions and answers may help you.
What is the Zofran controversy about?
Typically, Zofran is prescribed to cancer patients who experience nausea and vomiting while undergoing chemotherapy and radiation treatments. However, Zofran was also promoted for the treatment of morning sickness in pregnant women. Since this practice began, numerous medical journals have presented evidence suggesting a link between Zofran use and birth defects, leading medical professionals to conclude that the medication should not be prescribed for morning sickness in the first trimester.
How does Zofran work?
Zofran (ondansetron) blocks chemicals in the body responsible for nausea and vomiting. Pregnant women are typically prescribed the pill form of Zofran.
What are some birth defects caused by Zofran?
- Musculoskeletal anomalies
- Mouth deformities
- Heart defects
An infant death has been reported. Several infants were of low birth weight and several others were classified with “fetal growth restriction”.
What are some other side effects of Zofran?
- Rashes, hives, and itching
- Shortness of breath
- Body swelling
- Irregular heartbeat
- Dizziness and fainting
- Difficulties in breathing and swallowing
Have studies proven that Zofran taken during the first trimester causes birth defects?
Numerous studies have been conducted across the globe. One 2011 study supported by a grant from the Centers for Disease Control and Prevention (CDC) states that Zofran doubles the risks of birth defects. A Danish study of 600,000+ women prescribed Zofran were monitored and it was concluded that the risk of birth defects was low. However, another study was presented on the same day by another group of Danish doctors indicating that a two-fold increase in infant heart defects, after following 900,000 pregnant women who took Zofran.
Are people currently suing Zofran’s manufacturer?
Birth injury lawsuits have been filed by mothers against its maker, GlaxoSmithKline. The United States Department of Justice also filed a lawsuit against Glaxo in 2012, ending in a settlement in the amount of of three billion dollars. Glaxo did not admit any wrongdoing in the settlement agreement.
Has Zofran been recalled?
Despite potential risks, the FDA has not recalled Zofran. Physicians have a legal duty to inform pregnant patients of the risks associated with Zofran prior to prescribing it, but are also legally allowed to prescribe the medication as they see fit.
Which types of damages can I sue for?
- Medical expenses
- The permanency of the injury
- Pain, suffering, and mental anguish
- Loss of income or ability to work
- Conscious pain and suffering of a loved one prior to death
- Funeral expenses
Women prescribed Zofran in the first trimester whose children were subsequently born with birth defects are encouraged to consult with a Zofran lawsuit attorney to learn more.