Children Allegedly Harmed through Promotion of Zofran for Off-Label Use
Lawsuits filed against GlaxoSmithKline (“GSK”), the manufacturer of Zofran, allege GSK promoted Zofran for purposes that were not approved by the U.S. Food and Drug Administration (“FDA”), so-called “off-label uses.” In 1991, the FDA approved Zofran to treat nausea and vomiting in chemotherapy, radiation therapy, and post-operation surgery. However, the FDA did not approve Zofran to be taken by pregnant women. Lawsuits against GSK allege it marketed Zofran for the off-label use as an anti-nausea drug during pregnancy to treat “morning sickness” to women in their first trimester of their pregnancy.
Recent studies suggest a causal connection between infants whose mother took Zofran during the first trimester of the pregnancy and were born with the following devastating injuries:
- Cleft palate
- Cleft lip
- Heart defect (heart murmur and atrial septal defect or a “hole in the heart”)
- Other birth defects, such as born with only one kidney
If you or someone you know was prescribed Zofran for morning sickness during the first trimester of pregnancy and had a baby with a heart defect, cleft palate, cleft lip, or other birth defects after taking Zofran during the pregnancy, you may be entitled to compensation.
The Danger of Zofran to Pregnant Women
The purpose of FDA approval of drugs is to make sure a drug is safe for the particular purpose(s) it receives approval to treat. While Zofran received approval to treat nausea and vomiting from chemotherapy, radiation therapy, and post-operation surgery, Zofran did not receive approval for use by pregnant women.
The FDA did not review Zofran’s safety when taken during pregnancy. Animal studies suggest that Zofran passes through the placenta to the baby, thus potentially increasing the likelihood of birth defects.
To find that your child or the baby of a friend or loved one sustained defects or health trouble that could have been prevented, can be both a financial hardship and emotionally traumatic.
At Bachus & Schanker, LLC, Our Passion is Justice.
We will fight to achieve justice for you. If you or somebody you know took Zofran during the first trimester of her pregnancy and had a baby with a birth defect, call our office for a free case consultation with an Attorney.
Speak to a Zofran Attorney Today. Contact us now.