NEW YORK, March 1, 2015 /PRNewswire-USNewswire/ -- A new study published this month is adding to an accumulating body of evidence suggesting that ondansetron, an anti-nausea medication sold under the brand name Zofran (http://www.zofranlawsuit2015.com/), may affect a developing fetus when used to treat expectant mothers, according to Bernstein Liebhard LLP. The study, which was published in the February 2015 issue of Clinical Pharmacology and Therapeutics, involved 20 nonpregnant women and 40 pregnant women following a single administration of 4 or 8 mg of ondansetron as part of an investigation of a possible treatment for neonatal abstinence syndrome. After taking samples from umbilical cord blood, as well as from the infants after birth, the authors of the study determined that the drug is associated with rapid transplacental transfer and longer elimination half-life in neonates compared to their mother.
"This study comes as Zofran lawsuits begin to be filed in federal courts, all of which allege off-label use of the drug to control nausea and vomiting in pregnancy increases the risk that a baby will be born with serious birth defects," says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm is offering free legal reviews to any family whose child was allegedly harmed due to pre-natal exposure to Zofran.
Zofran Litigation
Zofran, known generically as ondansetron, is approved to treat nausea and vomiting in patients undergoing certain types of radiation and chemotherapy treatments. It is also indicated to alleviate post-operative nausea or vomiting. However, Zofran and other forms of ondansetron are not indicated to treat expectant mothers who suffer from nausea and vomiting during pregnancy. The U.S. Food & Drug Administration (FDA) currently classifies Zofran in Pregnancy Category B, which means that while animal studies have revealed no evidence of harm to the fetus due to the medication, there have been no adequate and well -controlled studies of the drug's effects in pregnant women.
According to court documents, at least two Zofran lawsuits have been filed in federal courts this month on behalf of children who allegedly suffered severe heart birth defects due to their mothers' use of Zofran to treat severe nausea and vomiting. The first was filed on February 12th, in the U.S. District Court, Eastern District of Pennsylvania by a woman who alleges her use during both of her pregnancies in 2004 and 2006 caused her two children to be born with serious heart abnormalities. (Case 2:15-cv-00709-PD) On February 16, 2015, a second complaint was filed in the U.S. District Court, District of Massachusetts on behalf of a child who was allegedly born with several congenital heart abnormalities due to his mother's use of Zofran during the first trimester of pregnancy. (Case 1:15-cv-10429)
Court records indicate that both of these lawsuits accuse GlaxoSmithKline of failing to warn patients that Zofran could harm a developing fetus, and of improperly promoting the off-label use of the drug to treat nausea and vomiting in pregnancy. The complaints point out that in 2012, the company agreed to pay $3 billion to resolve charges with the U.S. Department of Justice regarding the improper promotion of a number of medications, including the alleged off-label marketing of Zofran as a treatment for nausea and vomiting related to pregnancy.
Parents of children who were born with serious birth defects allegedly related to their mother's use of Zofran during pregnancy may be entitled to file their own claims against GlaxoSmithKline. To find out more about available legal options, please visit Bernstein Liebhard LLP's website, or call the Firm directly at (888) 340-4807.
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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ATTORNEY ADVERTISING. © 2015 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (888) 340-4807. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Contact Information:
Sandy A. Liebhard, Esq.
Bernstein Liebhard LLP
info (at)consumerinjurylawyers(dot)com
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SOURCE Bernstein Liebhard LLP
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