Please contact our Houston Zofran lawyers for a free dangerous drug case evaluation if you or someone you know used the medicine while pregnant between 2000 and 2015 and had a baby with a cleft palate, cleft lip, heart defect, or any other major issues.
Read our latest article: Morning Sickness Drug Zofran is Linked to Birth Defects
Zofran (Ondanestron) is a medication used to reduce nausea and vomiting caused by surgery, chemotherapy, or radiation. By changing serotonin levels in the brain, the FDA has only approved Zofran for cancer patients recovering from chemotherapy. The medicine maker, GlaxoSmithKline, used aggressive marketing to get doctors to prescribe Zofran for “off-label” purposes such as treating morning sickness in pregnant women. There is no information on the medicine label about the possibility of birth abnormalities.
A 2011 study found that mothers who took Zofran during their first trimester of pregnancy were twice as likely to have a child with a cleft pallet. A cleft palate occurs if the tissue that makes up the roof of the mouth does not join together completely during pregnancy. This generally occurs between the 6th and 9th week of pregnancy.
Additionally, a 2013 study found a doubling in the prevalence of major congenital heart defects in children whose mothers redeemed a prescription for Zofran in the first trimester of pregnancy. These heart defects can include:
Research published in December 2014 by Dr. Gideon Koren studied more than 900,000 Danish women. Koren found a 2-fold increased risk for cardiac malformations for women who took Zofran. This also led to a 30% increased risk of major congenital malformations. Koren also compared metoclopramide to Zofran. Metoclopramide is also used to treat morning sickness but it was not associated with any birth defects in the first trimester.
Zofran has been linked to an increased risk of the following birth defects:
In 2012, The United States Department of Justice filed a lawsuit claiming the manufacturer GlaxoSmithKline engaged in promoting “Off-Label” use promoting several drugs including Zofran. A $3 billion dollar settlement was the outcome of this litigation.
GlaxoSmithKline admitted that studies had not been conducted with pregnant woman using Zofran.
Women who took Zofran for nausea and vomiting and had a baby with a birth defect are now suing the manufacturer. Our firm is representing these women. If you or someone you know had a baby with a cleft palate, cleft lip or heart defect after taking Zofran, please contact our Houston attorneys for a free case evaluation.
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