San Diego, CA, July 22, 2015 --(PR.com
)-- For patients undergoing surgery or chemotherapy, a common treatment for the associated nausea and vomiting is Zofran (ondansetron), an anti-nausea medication manufactured by GlaxoSmithKline and approved by the U.S. Food and Drug Administration (FDA) in 1991. Because of its anti-nausea properties, Zofran is also frequently used for other off-label purposes, including as a treatment for pregnant women suffering from a severe form of morning sickness known as hyperemesis gravidarum according to the Zofran Lawsuit Help Center
. However, this particular use for Zofran has not been approved by the FDA, and studies have shown that Zofran use in pregnancy may actually put unborn babies at risk for a number of severe birth defects – a risk that outweighs the anti-nausea benefits the medication may have for expectant mothers.
Alleged Zofran Birth Defects
Women across the country who have become pregnant while taking the medication accuse GlaxoSmithKline of allegedly failing to provide the public with adequate warnings about the risk of Zofran birth defects. Recent reports indicate that GlaxoSmithKline knew as far back as 1992, that Zofran was capable of passing through the human placenta and putting unborn babies at risk for serious harm. Allegedly despite this knowledge, the drug maker has continued to market Zofran as a treatment for morning sickness in pregnant women, potentially putting exposed babies at risk for serious birth defects, including:
• Cleft lip
• Cleft palate
• Heart malformations
• Fetal growth restriction
• Musculoskeletal defects
• Spina Bifida
• Heart murmurs
• Atrial septal defects
• Ventricular septal defects
• Kidney abnormalities
Despite these alleged Zofran birth defects, the FDA has yet to issue an official announcement warning consumers and the medical community about the alleged potential for Zofran to interfere with fetal development. The agency has, however, classified Zofran as a pregnancy Category B medication, which means there is no adequate or well-controlled research analyzing the safety of Zofran use among pregnant women.
Studies Highlighting Alleged Zofran Pregnancy Risks
As concerns continue to mount regarding the possible alleged risks of Zofran use during pregnancy, a growing body of research has identified a host of birth defects that may impact babies exposed to the controversial anti-nausea drug in utero. More recent studies have refined the conclusions of previous research, but allegedly initial reports of birth defects caused by Zofran use in pregnancy date back more than a decade. In September 2004, for example, a study published in the medical journal BJOG: an International Journal of Obstetrics and Gynaecology identified case reports linking exposure to Zofran in utero to an increased risk of urethral birth defects in boys, known as hypospadias.
Since then, a number of Zofran studies have examined the alleged pregnancy risks tied to the morning sickness drug, and allegedly between November 2011 and January 2012, two separate studies found that the use of Zofran during pregnancy to combat nausea and vomiting from morning sickness was associated with a 2.4-fold increased risk of cleft lip and cleft palate birth defects in babies. Another study published in the journal Reproductive Toxicology in December 2014, found that Zofran treatment during the first trimester of pregnancy doubled an exposed baby’s risk of “hole in the heart” birth defects, and increased by 62% his or her risk of heart birth defects overall.
Contact a Zofran Birth Defect Lawyer Today
The conclusions reached in these Zofran birth defect studies are especially alarming, considering the fact that the anti-nausea drug may allegedly pose the highest risk of harm when taken during the first trimester of pregnancy – a time when many women experience the worst bouts of morning sickness. In fact, statistics show that allegedly approximately one million women take Zofran or its generic counterpart, ondansetron, every year. If you or your child has suffered life-altering birth defects you believe may have been caused by exposure to the morning sickness drug Zofran in utero, consult an experienced Zofran lawyer today to discuss your options for legal recourse. You may be entitled to financial compensation for your child’s injuries and future medical bills, which you can pursue by filing a Zofran birth defect lawsuit against GlaxoSmithKline. For more information on Zofran birth defect lawsuits, please visit http://drug-lawsuits.com/