Zofran was approved by the U.S. Food and Drug Administration (FDA)
to treat nausea and vomiting caused by chemotherapy and
radiation. The drug was also prescribed to treat morning sickness in
pregnant women, but it was not approved by the FDA for this use.
The Center for Birth Defects Research and Prevention recently published a
study isuggesting that women who used Zofranduring the first
trimester of pregnancy had a twofold increase risk of having a child
with birth defects.
Possible Zofran defects may include cleft lip, cleft palate, and congenital heart defects.
Although Zofran was not approved by the FDA for morning sickness,
GlaxoSmithKline (GSK) promoted off-label use of the drug. GSK agreed to
pay $3 billion in 2012 to settle numerous allegations including
illegally marketing Zofran® for non-approved use.
Mothers who took
Zofran during pregnancy and had a child with cleft lip, cleft palate,
or heart defects may be entitled to compensation. Contact a Nelson Bryan and Jones (205-387-7777) to find out if you and your child are eligible for compensation.
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