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    Multiple Research Studies Establish Possible Link Between Zofran & Birth Defects

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    Multiple epidemiological studies have begun to establish an association between the drug ondansetron, marketed by GlaxoSmithKline as Zofran, and severe birth defects. Joined by an alliance of distinguished plaintiffs’ attorneys, Monheit Law discusses this most recent research, along with allegations in filed lawsuits (Eastern District of Pennsylvania case number 2:15-cv-00709PD and District of Massachusetts case number 1:15-cv-10429) that GlaxoSmithKline was aware of these dangers but did nothing to warn the health community or public.

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    Zofran, also known as ondansetron, is frequently prescribed to pregnant women for morning sickness. While the drug was never approved for this purpose, it is not illegal for physicians to prescribe medications “off-label.” However, pharmaceutical manufacturers are prohibited from marketing their products for unapproved uses.

    In 2012, the US Department of Justice accused GlaxoSmithKline, Zofran’s manufacturer, of advertising Zofran directly to obstetricians and gynecologists as a treatment for morning sickness.

    GlaxoSmithKline has never tested Zofran’s effects for morning sickness in pregnant women, and has presented no evidence that the medication is safe for unborn babies. In fact, several large-scale epidemiological studies have suggested the opposite: around the world, multiple teams of researchers have observed a marked increase in the likelihood of birth defects among women exposed to ondansetron during early pregnancy.

    In association with the US Centers for Disease Control, researchers at Harvard University and Boston University’s Slone Epidemiology Center reviewed data pertaining to 10,383 births [Anderka M, Mitchell AA, Louik C, Werler MM, Hernández-Diaz S, Rasmussen SA, et al. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol. 2012;94(1):22–30. Epub 2011 Nov 19.]. While a majority of the women reported experiencing nausea and vomiting during the first trimester of pregnancy, only 15.4% had been prescribed a version of Zofran or its generic equivalent. Comparing both groups, the researchers found that pregnant women who had taken ondansetron during the first trimester of pregnancy were 2.37 times more likely to deliver a baby with cleft palate. Cleft palate, a form of orofacial defect, involves a large split that runs along the roof of a child’s mouth. This abnormal opening makes feeding, breathing and speech difficult and can require as many as five surgeries to fully repair.

    In Western Australia, researchers reviewed every birth record filed between 2002 and 2005. In total, the study included 96,968 births [Off-Label Use of Ondansetron in Pregnancy in Western Australia by Lyn Colvin, Andrew W. Gill, Linda Slack-Smith, Fiona J. Stanley, and Carol Bower, BioMed Research International Volume 2013 (2013), Article ID 909860, 8 pages]. Only 0.25% of the women studied had taken ondansetron during their pregnancies. The study concluded that women prescribed ondansetron in the first trimester were 20% more likely to deliver babies with major birth defects. Children delivered by women prescribed ondansetron were reported to be 6 times more likely to have rare kidney defects.

    Reviewing birth records reported in Denmark between 1997 and 2010, a team of Danish researchers investigated a total of 903,207 births [Andersen JT, Jimenez-Solem E, Andersen NL, et al. Ondansetron Use in Early Pregnancy and the Risk of Congenital Malformations - A Register Based Nation wide Control Study. International Society of Pharmaco-epidemiology Montreal, Canada; 2013. Abstract 25, Pregnancy session 1]. Of that total, 1,368 pregnant women had redeemed prescriptions for ondansetron in the first trimester. While only 3.5% of women not prescribed ondansetron delivered children with birth defects, 4.7% of those who had taken the drug did. The study concluded that women prescribed ondansetron were 4.8 times more likely to give birth to children with “atrioventricular septal defects,” a congenital disorder in which the heart fails to form properly.

    Swedish researchers found similar results. Using birth records that spanned from 1998 to 2012, the Swedish team identified 1,349 children born to women exposed to ondansetron during early pregnancy [“Use of ondansetron during pregnancy and congenital malformations in the infant.” Danielsson B, Wikner BN, Källén B - Reprod Toxicol. 2014 Dec;50:134-7. doi: 10.1016/j.reprotox.2014.10.017. Epub 2014 Oct 31.] Compared to women who had not been prescribed the drug, mothers who took ondansetron were 1.62 times more likely to deliver babies with “cardiac septum defects,” a category of congenital heart conditions that includes atrioventricular septal defects.

    Early in 2015, two pediatric patients arrived at a Pennsylvania emergency room with symptoms of gastroenteritis. According to the responding physicians, ondansetron is often used “off-label” to treat the vomiting that this condition can cause. After the drug was administered, both patients experienced abnormally fast heart beats, or tachycardia. This eventually led to ventricular fibrillation and death. Although this result would not normally suffice as clinical evidence, the two doctors published an account of their experience in the journal Pediatric Emergency Care. Their article was titled “Fatal Cardiac Arrest In 2 Children: Possible Role Of Ondansetron.”

    GlaxoSmithKline has denied the Department of Justice’s claims that Zofran was unlawfully marketed to OB / GYNs. And while the company opposes any and all allegations of wrongdoing, it settled the DOJ’s case for a historic $3 billion.

    Recent lawsuits allege that GlaxoSmithKline’s unlawful corporate practices go deeper. The complaints claim that the company knew of Zofran’s potential dangers for fetal development, but did nothing to warn the health community or public. If these allegations prove true, women who were prescribed Zofran and then delivered babies with birth defects may deserve substantial compensation.

    Monheit Law urges families with more questions about Zofran and the possibilities of litigation to visit zofranlegal.com.

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