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How does Zofran cause birth defects?


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Birth defects may be caused by drug exposure during early pregnancy. This was first evidenced by the thalidomide tragedy during the post-war era of the 1960’s. Thalidomide was a sleeping pill and tranquilizer marketed as safe for use in pregnant women. Unfortunately, it was anything but safe for the fetus. Severe birth defects secondary to Thalidomide prompted the start of the Food and Drug Administration’s (FDA) drug approval and monitoring systems. According to The Thalidomide Tragedy: Lessons for Drug Safety and Regulation, “They advertised their product as “completely safe” for everyone, including mother and child, “even during pregnancy,” as its developers “could not find a dose high enough to kill a rat.” This is analogous with GlaxoSmithKline and their advertising of Zofran as safe during pregnancy.

Additionally, reproduction studies testing Zofran and it’s teratogenic effects were only performed on pregnant rabbits and rats, much like thalidomide. The Zofran Tablet Prescribing Information states verbatim,  “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.” The ramifications from a lack of testing on human subjects was substantiated with thalidomide. It’s ironic how the thalidomide tragedy catalyzed the FDA’s rigorous drug testing standards yet these standards don’t appear to have been applied to Zofran.

Around the 1960’s, it was discovered thalidomide also alleviated morning sickness. It was subsequently prescribed for off-label use in pregnant patients.  Prescribing drugs for off-label purposes, or purposes other than those for which the drug was approved, is still a common practice in many countries today, including the U.S. In the U.S. today, Zofran is prescribed off-label to alleviate morning sickness in pregnant women. And similar to Thalidomide, it may cause birth defects.

So, how do drugs like Zofran cause birth defects? In the case of Thalidomide, it was discovered that thalidomide caused malformations by interacting with the DNA of the dividing embryonic cells. The research regarding Zofran and it’s interaction with DNA of the developing fetus is still uncertain. However, Zofran has potential to cross the placental barrier. According to Placental Transfer of Ondansetron during Pregnancy, the overall extent of placental transfer, the ratio of fetal tissue to maternal plasma ondansetron (Zofran) concentration was considered significant. In other words, the dosage’s rate of transfer from the mother’s blood stream to the unborn child is significant. The study also suggests Zofran readily passed through the human placenta in the first trimester. A significant amount was found in fetal tissue and amniotic fluid.

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Mom Says Zofran Caused Daughter’s Heart Defect


On March 17th, a ValleyNewsLive.com segment reported on a North Dakota woman treated with Zofran, the antiemetic, during her pregnancy. In an interview, Kylee Riesen discussed taking Zofran almost daily during the early months of her pregnancy to control her nausea and vomiting. She suspects Zofran (Ondansetron) caused her now 2-year-old daughter’s congenital heart defect (CHD). Her daugther, Arianah, will undergo open heart surgery in May to fix the holes in her abnormally enlarged heart.

In 2014, Dr. Gideon Koren of the The Motherisk Program of Toronto, Canada released a study detailing fetal safety concerns regarding Zofran. The study showed a “2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations.” The article also indicates how Zofran was never tested on pregnant women, and mentions that recent studies suggest the drug places the developing fetus at increased risk for birth defects.

This is only the latest of several reports raising awareness about the link between Zofran and significant birth defects. Our attorneys receive numerous inquiries from families with similar concerns. We continually follow developments regarding Zofran and it’s association with birth defects as part of our firm’s ongoing investigation into this matter. Our attorneys have decades of experience representing victims of dangerous drugs and defective medical devices. We currently evaluate potential Zofran cases on behalf of families whose child was allegedly born with a birth defect secondary to in utero exposure to this drug.

You can follow Arianah’s Heart Journey on Facebook: https://www.facebook.com/ArianahsHeartJourney

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Zofran Blamed for Birth Defects in Two New Lawsuits


Mothers, Cheri Flynn and Tomisha LeClair, were unaware there was a risk of birth defects when they took Zofran, an anti-emetic, for morning sickness during their pregnancies. The physicians prescribing Zofran were also unaware of these risks. However, pharmaceutical company GlaxoSmithKline, the manufacturers of Zofran, knew about the potential chance of birth defects, and illegally marketed and promoted the drug to physicians as safe for use in pregnant women.

Zofran (Ondansetron) is not approved by the Food and Drug Administration (FDA) as a treatment for morning sickness, or nausea and vomiting of pregnancy (NVP). According to FDA regulations, doctors may prescribe drugs for off-label use, but drug manufacturers may not promote such uses. Off-label use is using drugs for unapproved indications. In this case, Zofran is approved for treatment of nausea and vomiting related to chemotherapy, radiation, and surgery but not nausea and vomiting of pregnancy. Therefore, doctors may legally prescribe Zofran “off-label” to pregnant women but GlaxoSmithKline cannot legally promote those uses.

Ms. Flynn and Ms. LeClair filed product liability lawsuits against GlaxoSmithKline in February 2015. They both claim Zofran (Ondansetron) use during their respective pregnancies caused severe birth defects in their children. The respective lawsuits assert GlaxoSmithKline failed to warn consumers and medical professionals of the link between Zofran (Ondansetron) and an elevated risk of congenital heart defects, cleft lip and cleft palate. Ms. Flynn took Zofran during two of her pregnancies. Her complaint alleges taking Zofran during her pregnancies caused congenital heart defects in her children who were born in 2004 and 2006; Ms. LeClair claims her daughter suffers from heart malformations and a permanent developmental delay secondary to  Zofran (Ondansetron) use during her pregnancy. In addition, the lawsuits contend GlaxoSmithKline knew about the potential risks associated with Zofran (ondansetron) since initially manufacturing the drug in the 1980s.

This is not GlaxoSmithKline’s first time falsely misleading the public. In 2012, the United States government actually sued GlaxoSmithKline for promoting and marketing Zofran for off-label uses to doctors.  The lawsuit explicitly stated, “GSK knowingly: (a) promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis or pregnancy-related nausea); (b) made and/or disseminated unsubstantiated and/or false representations or statements about the safety and efficacy of Zofran; and (c) offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran.”  GSK plead guilty and eventually paid a $3 Billion fine in order to resolve fraud allegations and failure to report safety data. The failure to report safety data refers to the fact that Zofran has never been adequately tested and determined safe for use in pregnant women.

If you took Zofran (Ondansetron) in your first trimester of pregnancy, and your child was born with birth defects, call us for a free case consultation or fill out our confidential online form. We focus on your case, so you can focus on yourself.

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GlaxoSmithKline Promoted Zofran Off-Label Use


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Zofran (Ondansetron) is not approved by the Food and Drug Administration (FDA) as a treatment for morning sickness, or nausea and vomiting of pregnancy (NVP). According to FDA regulations, doctors may prescribe drugs for off-label use, but drug manufacturers may not promote such uses. Doctors may legally prescribe Zofran “off-label” to pregnant women but the manufacturers of Zofran cannot promote those uses. Off-label use is using drugs for unapproved indications. In this case, Zofran is approved for treatment of nausea and vomiting related to chemotherapy, radiation, and surgery but not nausea and vomiting of pregnancy.

GlaxoSmithKline (GSK) manufactures Zofran. They directly promoted and marketed Zofran for off-label uses (i.e. nausea and vomiting of pregnancy) to doctors. This is illegal. In 2012, the United States government actually sued GlaxoSmithKline for these illegal practices. The lawsuit explicitly stated, “GSK knowingly: (a) promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis or pregnancy-related nausea); (b) made and/or disseminated unsubstantiated and/or false representations or statements about the safety and efficacy of Zofran; and (c) offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran.”  GSK plead guilty and eventually paid a $3 Billion fine in order to resolve fraud allegations and failure to report safety data. The failure to report safety data refers to the fact that Zofran has never been adequately tested and determined safe for use in pregnant women.

 

 

 

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Zofran and Kidney Malformation


Kidney Malformation

  • The kidneys filter blood and excrete waste and toxins via urine. We have two kidneys located posteriorly. In utero (in the womb), kidneys function at 10 weeks, in the first trimester. Unfortunately, most major birth defects occur within the first trimester.
  • Causes: A study, Off-Label Use of Ondansetron in Pregnancy in Western Australia, examined ondansetron (Zofran) use in pregnant women. The researchers found an increased risk of obstructive defects of the renal pelvis and ureter (tube expelling urine from kidneys). Additionally, there was a 20% increased risk of a major birth defect among children exposed to ondansetron (Zofran) in the first trimester. The study “could not conclude that ondansetron is safe to use in pregnancy…and found an increased risk of a major birth defect, preterm birth, shorter birth length, and maternal urinary tract infection”.

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