Bernstein Liebhard LLP: Studies Show Fetal Dangers of Zofran Use During Pregnancy and the Need for More Research

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May 29, 2015, 04:18 ET

NEW YORK, May 29, 2015 /PRNewswire-USNewswire/ -- As Zofran lawsuits filed against GlaxoSmithKline mount, court documents indicate that plaintiffs and their guardians allege the drug maker knew about the potential dangers posed to fetuses who are exposed to the medication during the first trimester of pregnancy, reports Bernstein Liebhard LLP.

A lawsuit filed on May 21, 2015 in the U.S. District Court, Eastern District of Arkansas by the parents of child who was born with a cleft lip alleges that GSK knew the dangers the drug could pose on unborn fetuses. The complaint says that animal studies conducted in the 1980s revealed that the active ingredient in Zofran crossed the placental barrier to the fetus, and indicated "toxicity, intrauterine deaths, and malformations in offspring.

A lawsuit filed in February by the mother of a child born with several congenital heart abnormalities in U.S. District Court, District of Massachusetts makes similar allegations. The suit claims that by 1992, GSK was receiving reports of birth defects associated with use of Zofran. The plaintiffs contend that by 2000, the company had received at least 32 reports of Zofran birth defects, and at least 200 more to date. Yet these reports were never disclosed to the very physicians who were prescribing the medication. (Case 1:15-cv-10429) [Filed February 16, 2015]

Both complaints note that GlaxoSmithKline agreed to pay $3 billion to resolve allegations by the U.S. Department of Justice that it was illegally promoting several medications, including the off-label marketing of Zofran as a treatment for morning sickness.

Studies Show Dangers of Zofran Use in First Trimester of Pregnancy

At least four studies have indicated that use of Zofran or its generic version by pregnant women may lead to an increased risk of serious birth defects. A study conducted by researchers at Harvard University, the U.S. Centers for Disease Control, and the Slone Epidemiology Center found that women who consumed ondansetron during their pregnancy were more than twice as likely to give birth to a child with cleft palate.

A study published in 2013 in BioMed Research International linked Zofran use during the first trimester of pregnancy to an increased risk major birth defects, preterm birth, and shorter birth length.

Danish researchers found that babies who were exposed to ondansetron in utero were more than twice as likely to be born with atrial and ventricular septal defects and more than four times as likely to have atrioventricular septal defects.

In 2014, research appearing in the journal Reproductive Toxicology found that babies who were exposed to Zofran during early pregnancy faced a statistically significant increased risk for cardiovascular defects, notable cardiac septum defects.

Children who were born with serious birth defects allegedly due to pre-natal Zofran exposure may be entitled to file claims against GlaxoSmithKline. To learn more, contact Bernstein Liebhard at 1-844-4-Zofran, or visit our website at http://www.demandazofran.com/.

About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3 billion on behalf of our clients. The Firm has been named by The National Law Journal to the Plaintiffs' Hot List, recognizing the top plaintiffs firms in the country, for the past 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since it was first published in 2003.

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Contact Information:
Sandy A. Liebhard, Esq.
Bernstein Liebhard LLP
info(at)demandazofran(dot)com

http://www.demandazofran.com/
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SOURCE Bernstein Liebhard LLP