Zofran, a drug originally approved for the treatment of nausea and vomiting
as a result of chemotherapy, radiation therapy, and surgery, is at the
center of increasing public scrutiny for its off-label use. Doctors have
been prescribing the drug to treat nausea and vomiting resulting from
morning sickness during pregnancy. Zofran has never been approved for
this use, and has resulted in dangerous side effects for pregnant women
and their babies. If were prescribed Zofran during pregnancy and your
baby was born with a birth defect, the attorneys at Goldstein & Hayes,
P.C. can help. Contact us today to discuss your case.
Zofran is Not Approved by the FDA for Treatment of Pregnancy-Induced Nausea
In fact, Zofran is not FDA approved at all for prescription during pregnancy.
The drug is currently still being investigated by the FDA to determine
the risks and dangers associated with taking the drug while pregnant.
GlaxoSmithKline, the manufacturer of Zofran, marketed the drug to doctors
for the treatment of pregnancy-induced nausea even though the dangers
of taking the drug during pregnancy had not been fully evaluated. GlaxoSmithKline
has admitted to some negligence in its promotion of Zofran. In 2012, the
company was sued by the U.S. Department of Justice, and agreed to pay
a settlement of $3 billion. The U.S. Department of Justice alleged that
among other things, GlaxoSmithKline illegally promoted off-label uses
of the drug, and also had bribed health care professionals to prescribe Zofran.
A Number of Studies Have Confirmed a Connection Between Taking Zofran During
Pregnancy and Increased Risk of Birth Defects
A number of reputable studies have demonstrated the connection between
Zofran and birth defects. Studies have found that taking Zofran while
pregnancy can result in:
A 30% increased risk of heart defects
A doubled risk of babies developing cleft lip and cleft palate
An increased risk of kidney malformations
Doctors are still prescribing Zofran to pregnant women today. Approximately
one million pregnant women were prescribed Zofran for the treatment of
morning sickness in 2014.
Many Women Have Initiated Lawsuits Against GlaxoSmithKline to Hold the
A number of women are holding GlaxoSmithKline responsible for its illegal
marketing of Zofran. Lawsuits are alleging that the company failed to
test the safety of prescribing Zofran during pregnancy and when the risks
and dangers became apparent, failing to disclose those risks. If your
family is among those impacted by Zofran, you should know you are not
alone. You can turn to our experienced
Atlanta injury attorneys for help. We are experienced in fighting for families, particularly in
birth defects or dangerous drug prescriptions.