About Zofran
About Zofran
As national product liability attorneys specializing in dangerous drug cases, The Sanders Firm is alarmed by recent reports and allegations involving Zofran pregnancy risks. Some families who have filed suit against manufacturer GlaxoSmithKline (GSK) argue that the anti-nausea medication is the direct cause of their child’s congenital birth defects. These are women who, under the care and direction of their doctors, took Zofran (ondansetron) on an off-label basis to alleviate debilitating symptoms of morning sickness. And while further research is warranted to determine fetal injury risks associated with the drug, many women are wondering if ondansetron is safe during pregnancy, and how a potentially hazardous product could be marketed for such a purpose if risk of fetal harm was indeed known.
In situations where personal injury litigation is warranted, it’s vital to have the right attorney on your side. Going up against a global drug manufacturer takes financial resources, determination and the legal savvy of a law firm specializing in complex pharmaceutical cases. Boasting nearly 50 years of combined litigation experience, The Sanders Firm leverages their skill and knowledge to ensure innocent victims are fairly compensated.
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Zofran prescribed off-label for morning sickness
Zofran is a type of 5-HT3 antagonist that stimulates gastric emptying while blocking serotonin. The drug was approved in 1991 to help treat cancer patients suffering nausea and vomiting caused by radiation therapy and chemo. Zofran is also approved by the FDA to help ameliorate nausea in post-operative patients, but the medication was never explicitly designed for use in pregnant women. Nevertheless, ondansetron has been prescribed to thousands of women in the throes of extreme morning sickness. Known as hyperemesis gravidarum, this condition affects a significant number of expectant mothers and is marked by persistent nausea and vomiting, dehydration, electrolyte imbalances and other serious side effects that pose risk to the health of mother and baby.
Women who are unable to find respite from the incapacitating effects of morning sickness must often resort to anti-nausea meds. Zofran is classified by the FDA as a category B pregnancy medication, indicating that animal trials have showed no risk of fetal injury. Though patients were assured of its safety, very few studies on Zofran have been conducted in human populations regarding birth defect risks, and results have proven confusing.
Studies involving Zofran birth defect risks
Fetal and maternal safety are of paramount concern when prescribing medications. Drugs that can breach the placental barrier and enter the baby’s bloodstream may pose a much higher risk of adverse effects to the developing fetus. According to an observational study published in the journal Clinical Pharmacology & Therapeutic, evidence of rapid placental transfer of Zofran merits additional investigation.
In 2013, research published in the New England Journal of Medicine placated concerns after finding that Zofran use during pregnancy was not associated with adverse fetal outcomes or birth defects. However, a large control study by the Slone Epidemiology Center and the CDC discovered a 2-fold increased risk of cleft palate linked to Zofran exposure.
Another study, which analyzed 900,000 births from the Danish Birth Registry found a two-fold risk of heart defects in infants whose mothers took Zofran while pregnant.
While the connection between Zofran use during pregnancy and fetal injury remains somewhat unclear, GSK is facing legal allegations that previous animal trials showed the drug’s toxicity, including intrauterine deaths and fetal malformations in rabbits and rats.
Further studies are needed to establish whether ondansetron poses risk for:
- Heart murmurs and atrial septal defects
- Cleft lip
- Cleft palate
- Kidney malformations
- Skull deformities
- Fetal growth restriction
- Fetal death
Emerging Zofran litigation
GlaxoSmithKline has already reached a settlement with the U.S. Department of Justice to resolve civil liability regarding the unlawful promotion of several of its medications, including Zofran, Paxil and Wellbutrin. The $3 billion settlement also resolved fraud allegations and the manufacturer’s failure to report crucial drug safety data. GSK denies any wrongdoing or liability, but a recent spate of lawsuits alleging Zofran-related birth defects questions the off-label promotion of the nausea med for morning sickness.
According to allegations leveled in a recent Zofran lawsuit filed in Massachusetts, GSK:
- Failed to disclose information about Zofran risks to women or their physicians
- Disseminated false representations about the safety and efficacy of Zofran for treatment of hyperemesis and pregnancy-related nausea
- Never undertook a single study before marketing Zofran to pregnant women
The plaintiff further contends that as early as 2000, GSK had received at least 32 such reports detailing birth defects caused by Zofran use during pregnancy. The mother, who had taken the anti-nausea drug to quell morning sickness during her first trimester, delivered a child with atrial septal defects, right ventricular hypertension, facial dysmorphia and hearing loss. Due to his substantial developmental delays, the child will be deprived of a normal and healthy life.
Plaintiffs in these product liability lawsuits bring claims for both compensatory and punitive damages, to help offset the astronomical costs of caring for a child afflicted with such disabilities. Compensation procured through a court award or settlement typically accounts for losses such as past and future medical bills, lost wages, loss of enjoyment of life, reduced capacity to earn, as well as pain and emotional suffering.
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