Zofran Birth Defects Lawsuit
Zofran birth defects cases require attorneys experienced in the litigation of dangerous drug injury cases. You deserve a top Zofran lawsuit attorney with a track record of success on your side through the entire Zofran birth defects lawsuit process. You need Zofran lawyers with the financial resources to take on drug company Glaxo Smith Kline. Our attorneys have collected over $900 million for our clients. Let us help you recover compensation for birth defects damages on your Zofran claim. Contact us today for a free, no obligation consultation.
What is Zofran?
Zofran (ondansetron) is a powerful anti-nausea drug manufactured by GlaxoSmithKline. It was approved by the FDA in 1991 to help cancer patients with the severe nausea and vomiting side effects of chemotherapy and radiation treatments. It also was approved to prevent and treat nausea and vomiting after surgery. GSK never conducted randomized controlled research studies to investigate the drug’s possible side effects in pregnant women. Zofran has never been approved by the FDA for use by pregnant women to treat morning sickness.
How Does Zofran Work?
Zofran works by blocking serotonin receptors in the brain and gut to prevent nausea messages from being sent to the part of the brain that initiates and controls the act of vomiting. When taken by pregnant women, it crosses the placenta barrier and is exposed to the fetus.
The GSK patent on Zofran expired in December 2006 and ondansetron, the generic version, began to be sold in the U.S..
Zofran for Morning Sickness?
Most pregnant women suffer nausea and vomiting (“morning sickness”) during the first trimester of pregnancy. Extreme morning sickness, called hypermemisis gravidarum, affects about 1% of pregnancies.
Zofran has never been approved by the FDA for use by pregnant women to treat morning sickness. Nonetheless, lawsuits claim GSK marketed Zofran “off label” as a safe and effective treatment for morning sickness. About a million pregnant women each year in the U.S. take the drug to treat morning sickness and nausea.
In 2012, GlaxoSmithKline reached a $3 billion settlement agreement with the government regarding the marketing of several drugs including Zofran.
GSK’s agreement with the U.S. Department of Justice settled claims that GlaxoSmithKline:
(a) “promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis and pregnancy-related nausea)”
(b) “made and/or disseminated unsubstantiated and false representations about the safety and efficacy of Zofran concerning the uses described in subsection (a) [hyperemesis and pregnancy-related nausea]”
(c) “offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran”
Zofran Birth Defects
Zofran side effects can injure a fetus during its development in the mother’s womb. An increased risk of several heart defects has been linked to Zofran use during pregnancy. Zofran heart defects include:
- Atrial Septal Defect (ASD)
- Ventricular Septal Defect (VSD)
- Heart Murmur
- Heart Valve Abnormality
- Hypoplastic Left Heart Syndrome (HLHS)
- Atrial Septal Defect (ASD)
- Patent Ductus Arteriosus (PDA)
- Tetralogy of Fallot (TOF)
- Transposition of the Great Vessels / Transposition of the Great Arteries
In addition to heart defects, the side effects of Zofran use during pregnancy have been linked to an increased risk of the following congenital birth defects:
- Cleft Lip
- Cleft Palate
If you or a loved one has has been affected by a Zofran birth defect, you may be entitled to recover substantial financial compensation. Let our experienced attorneys help you collect the money damages you deserve on your Zofran lawsuit claim.
Call us now at 800-845-6913 or submit the contact form on this page for a free no-obligation consultation with an experienced Zofran lawsuit attorney.