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216-621-3000Zofran is a drug manufactured by GlaxoSmithKline and prescribed during pregnancy to counteract and prevent nausea. Hailed by some as effective treatment for morning sickness, new evidence has come to light that the drug may in fact be responsible for causing heart problems in the baby in utero.
Zofran (the generic is called ondansetron hydrochloride) was approved by the FDA in 1991 to prevent nausea and vomiting caused by cancer treatment and surgery. It acts by blocking certain nerve messages.
The main concern for pregnant mothers who have taken Zofran is that it might cause heart defects in the baby. There is some evidence that it may cause jaundice, mouth deformities, kidney problems and musculoskeletal problems.
The current FDA-approved label of Zofran reads (as of September 2014), at section 8.1:
Reproduction studies have been performed in pregnant rats and rabbits at intravenous doses up to 4 mg/kg per day (approximately 1.4 and 2.9 times the recommended human intravenous dose of 0.15 mg/kg given three times a day, respectively, based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Lawsuits are now being filed against GlaxoSmithKline for Zofran, arguing that it causes heart defects and sometimes death to babies whose mothers use the drug while pregnant. The claims against GlaxoSmithKline include failure to warn of the drug’s dangers, and manufacture of a defective product.
Despite the label warning, GlaxoSmithKline may have aggressively marketed Zofran to obstetricians for use by pregnant women, approximately 50% of whom may suffer from morning sickness. If so, the company may be held responsible for injuries caused by the drug. Otherwise, doctors who prescribed the drug to pregnant women may also be responsible for prescribing a drug off-label.
It is irresponsible and greedy for a drug company to promote a drug that has not been adequately tested. If you took Zofran during pregnancy and your baby has any severe medical problem, including a heart defect, contact our medical malpractice attorneys at (440) 252-4399 or online for a free consultation.
