Recent research shows that taking Zofran during pregnancy may increase the risk of birth defects and serious health conditions for the mother and fetus. Congenital heart defects and physical deformities are among the birth defects that researchers believe are caused by Zofran, including cleft lip, cleft palate, musculoskeletal defects, jaundice, and other physical abnormalities. Zofran has never been approved for use in pregnant women by the FDA, yet many women were prescribed Zofran by their doctors. Pregnant women who took Zofran were led to believe the drug was safe when in fact, no definitive safety testing has ever been conducted regarding use during pregnancy.
Zofran (ondansetron) is a prescription drug used to prevent nausea and vomiting. It was approved by the FDA to relieve severe nausea and vomiting in patients undergoing chemotherapy treatment, radiation therapy, or surgery, has also been used widely to control nausea and vomiting in pregnant women. Research now demonstrates that Zofran is dangerous for fetuses and mothers, increasing the risk of birth defects, heart defects, and dangerous medical conditions.
Early animal-based research conducted by GlaxoSmithKline indicated that Zofran would move across the placenta to reach a growing fetus. No other research was conducted by the company to determine what effect Zofran would have on a growing fetus. Independent medical research has showed a growing fetus faces a significant risk to develop a range of birth defects if exposed to Zofran, particularly during the first trimester. The number of families stepping forward to file Zofran birth defects lawsuits is evidence that this problem may be widespread.
It is very common for mothers whose children were born with birth defects or health problems to wonder if they did something wrong. Mothers are not to blame for taking a drug that was prescribed by their doctor and presented as routine and safe. The blame for Zofran birth defects must be placed on the drug company. Aware that the drug had never been tested or proven to be safe for pregnant mothers of developing fetuses, GlaxoSmithKline still promoted Zofran to treat morning sickness, putting infants in harmâ€™s way.
The maker of Zofran, GlaxoSmithKline, paid the U.S. Justice Department $3 billion to settle a lawsuit in part related to the promotion of Zofran for off-label uses, including its use to control vomiting in pregnant women. The company allegedly marketed Zofran as a safe drug for use in pregnant women, though no research had been conducted on the subject and the FDA does not approve this use. Marketing a drug for an off-label use is a serious offense that potentially endangers the general public. In this case, growing fetuses were exposed to a heightened risk of serious birth defects, including congenital heart defects, from Zofran. Zofran use during pregnancy has been the subject of multiple studies conducted globally since 2004. The FDA added Zofran to a list of drugs being monitored for "potential... serious risks" based on adverse event reporting in the federal FAERS program in 2013.
The fetuses of mothers who take Zofran early in their pregnancy are most at risk of developing congenital birth defects. Fetuses exposed to Zofran early in the first trimester of development are most at risk for heart defects and other Zofran birth defects.
The FDA has never approved Zofran for treating morning sickness in pregnant women. GlaxoSmithKline paid billions in 2012 to resolve a lawsuit with the U.S. Department of Justice for promoting drugs for off-label uses. The illegal promotion of Zofran to pregnant women was included among those federal charges.
Early research showed that Zofran could pass across the placental barrier in mammals, yet no safety testing was conducted to assess the risk the drug may pose for fetal development. Although the company knew Zofran birth defects may be a potential danger, it engaged in marketing campaigns to promote the drug for use in pregnant women. From the time Zofran was first approved for use in the United States, GlaxoSmithKline knew the drug had not been deemed safe for pregnancy.
The mothers, parents, and families of babies born with birth defects possible linked to Zofran are eligible to file a birth defect lawsuit. Attorneys handling Zofran claims believe families whose babies developed birth defects and were exposed to Zofran in utero may be entitled to compensation.
While Zofran lawsuits are time sensitive, most mothers who took Zofran during their pregnancy will still be able to file a Zofran lawsuit now. To ask an attorney handling Zofran claims about relevant time limits for your case, contact our firm.
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