LAFAYETTE, La. — Louisiana woman claims her Zofran regimen caused her baby to be born with serious birth defects.
According to court documents, Kaden Lafleur was diagnosed with congenital heart defects, although there is no family history of such a malady.
Kaden underwent emergency corrective surgery almost immediately after birth and now faces long-term follow-up medical treatments.
The baby’s mother, Cicily Lafleur, says her physician prescribed Zofran off-label to alleviate her prepartum morning sickness, and although the Food and Drug Administration has not approved the drug for this use and no studies indicate such a practice is safe, GlaxoSmithKline aggressively markets Zofran as a panacea for almost all nausea and vomiting issues.
The lawsuit was filed in the U.S. District Court for the Western District Court of Louisiana, Lafayette Division.
Zofran Side Effects
Prior to 2000, most doctors prescribed doxylamine-pyridoxine in NVP (nausea and vomiting during pregnancy) cases; NVP is a potentially serious condition that, especially in the first trimester, can cause dehydration in both mother and baby.
Since 2000, thanks in large part to an aggressive marketing campaign, many practitioners prescribe Zofran or its generic equivalent (ondansetron) in these cases. While doxylamine-pyridoxine has been proven safe in over a quarter million pregnancies, there are fewer than 200 births that attest to Zofran’s safety.
Since the first trimester is so important to fetal development, researchers theorize that Zofran and other 5HT3 receptor antagonists, which block serotonin reception, often have devastating impacts on the fetus. Possible birth defects include:
- Heart Problems: As was the case with Baby Kaden, these issues require immediate surgery and extensive follow-up.
- Cleft Palate: Some corrective physical surgeries can be delayed until the baby is older and stronger, but generally speaking, cleft palates require immediate attention
- High Blood Pressure: This condition may get worse with age and follow the young children for the rest of their lives.
The FDA first warned about the link between Zofran and birth defects in 2011, but GSK has consistently denied any connection between the two.
Our Dangerous Drug Lawyers Can Help
Our dangerous drug attorneys can help if you or someone you care about was injured during or after ingesting Zofran. Lawsuits have been filed against the drug makers by both patients and their families seeking compensation for injuries caused by the dangerous drug. You may be entitled to a settlement.
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