Did you take Zofran® During Pregnancy?*
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Zofran® was Prescribed To Pregnant Women For Morning Sickness.
Zofran® was NOT recommended or tested for use in pregnant women.
What is Zofran®?
Zofran® (ondansetron) was invented in the 1980’s in England and patented by drug manufacturer GlaxoSmithKline in the United States. The Food and Drug Administration approved Zofran® in 1998 to treat nausea and vomiting in chemotherapy and surgery patients. Zofran® was NOT approved for use by pregnant women for morning sickness. In 2012 GlaxoSmithKline settled claims brought by the United States government for marketing drugs, including Zofran®, for “off-label” or “unapproved” uses.
Can Zofran® cause birth defects?
- A 2013 medical journal report from TDM Journal Club cautioned against ondansetron (Zofran®) for the treatment of morning sickness. Researchers cited safety concerns for both the mother and the unborn child. In comparing studies from Denmark, researchers noted:
- A two-fold increased risk of heart defects. Cardiac malformation incidents doubled when ondansetron was used in the first trimester of pregnancy.
- Risks to mothers included abnormal heart rhythms and electrolyte imbalance, and life-threatening drug interactions between ondansetron (Zofran®) and anti-depressant medications.
Other studies have raised concerns about ondansetron (Zofran®)
- More than double the risk of cleft palate. A January 2012 study of more than 9,000 women by the Sloan Epidemiology Center and the Centers for Disease Control and Prevention detected twice the risk for cleft palate associated with ondansetron (Zofran®) use in the first trimester of pregnancy.
- A 2006 study of 41 women in their first trimester were given ondansetron (Zofran®). The drug was present in every fetal tissue sample, indicating that Zofran® crosses the human placenta during pregnancy.
- Twenty Canadian women who took Zofran® during 2012 reported birth defects and two infant deaths to the U.S. Food and Drug Administration. In June 2014 the Canada Toronto Star reported that some doctors suspected a link between (Zofran®) and heart, mouth, and musculoskeletal abnormalities. Musculoskeletal abnormalities include club foot, joint, limb, facial, and vertebral malformation.
In July 2012 Zofran® manufacturer GlaxoSmithKline (GSK), while denying any wrongdoing, settled what the United States Department of Justice called the “largest health care fraud settlement in U. S. history.”
Without admitting liability, GlaxoSmithKline paid $3 billion ($3,000,000,000) to settle certain criminal and civil actions brought by the United States. A Settlement Agreement between the United States et al. and GlaxoSmithKline dated June 28, 2012 stated that GSK expressly denied the allegations.
In the Settlement Agreement, the United States continued to maintain that its allegations were “well-founded.” The United States alleged that GlaxoSmithKline had “knowingly” promoted Zofran® for non-approved (“off-label”) use, including pregnancy-related nausea. The United States also claimed that federal health care programs were billed for fraudulent purchases of Zofran®.
While denying the allegations, under the Settlement Agreement GlaxoSmithKline paid more than $54 million to resolve charges that GlaxoSmithKline had violated a Federal Anti-Kickback Statute by paying health-care professionals to prescribe Zofran® and other medications.
The Agreement listed:
If You Took Zofran® And Your Baby Had A Birth Abnormality
Please contact us now at (800) 432-4652 For A Free, Confidential Consultation.
You are not alone.
Mothers who took this drug did not know that Zofran® had not been tested for use during pregnancy. You and your child may be legally entitled to compensation for pain and suffering, medical costs, loss of income, emotional distress and other damages.
Call Litster Frost Injury Lawyers at (800) 432-4652. Our legal team has successfully litigated medical and product liability cases nationwide.
If you took Zofran® during pregnancy and later learned of a birth abnormality, please tell us your story and let us help you.
Call us now at (800) 432-4652, click the chat button to the right or submit the form below for a free, no-obligation confidential consultation.
* Individual cases are evaluated and compensated on their own merits.