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Research validates Zofran risk of birth defects

Birth_Defects_Baby.jpgLong before there were Zofran lawsuits, there were studies that showed a relationship between the anti-nausea drug and birth defects. These studies would appear to vindicate the parents who have filed lawsuits against defendant GlaxoSmithKline, the drug's manufacturer.

In the meantime, a woman who has used the drug during pregnancy and whose child has had a birth defect may call toll-free 1-866-LAW-2400 for a free legal analysis of whether there is an entitlement to compensation for medical expenses and for other losses. The Zofran attorneys at Reich & Binstock, who operate in all 50 states, offer a free consultation.

Zofran, the generic name of which is ondansetron, "is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery," according to the U.S. Food and Drug Administration. The agency added, "It is in a class of medications called 5-HT3 receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting."

The FDA approved Zofran in the early 1990s. The manufacturer promoted the drug more recently to treat morning sickness in pregnant women. Some of the research into the side effects of Zofran suggested that the use of Zofran during pregnancy can lead to birth defects.

For instance, in August 2013, researchers in Denmark examined data that was collected from 1997 to 2010 by the Danish Birth Registry. That study, "detected a 2-fold increased risk of cardiac malformations with ondansetron ... leading to an overall 30 percent increased risk of major congenital malformations," according to an article that the American Journal of Obstetrics and Gynecology published in August 2014.

That very same article referred to a study that was published in 2012. The authors wrote, "Of potential importance, a recent large case control study by the Sloan epidemiology unit and the Centers [for] Disease Control and Prevention, has reported a 2-fold increased risk for cleft palate associated with ondansetron taken for NVP in the first trimester of pregnancy."

NVP stands for nausea and vomiting of pregnancy.

The authors wondered in writing whether women need to take Zofran or its generic version for morning sickness, given the emergence of seeming safer alternatives. The AJOG writers explained, "In April 2013, the Food and Drug Administration approved the combination of doxylamine and pyridoxine, specifically for nausea and vomiting in pregnancy symptoms. Now that a safe and effective drug is available in the United States, there is no reason for women to be exposed to a drug of unproven maternal and fetal safety."

Staying in Europe, another study evaluated data from a years ago and came to a conclusion that also exposed Zofran in a negative light. The researchers were associated with the National Board of Health and Welfare in Sweden. Their article appeared in the December 2014 edition of the medical journal Reproductive Toxicology.

In Sweden, the team examined records of births and of prescribed drugs to determine the outcomes when expectant mothers used Zofran in early pregnancy from 1998 through 2012.

In regard to the birth defects risk associated with Zofran, the Swedish authors wrote, "The risks for a cardiovascular defect and notably a cardiac septum defect were increased and statistically significant."

Around the end of data collection for the Swedish study, the U.S. Justice Department charged Zofran maker GlaxoSmithKline with health care fraud. The corporation "agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company's unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices," according to a July 2012 Justice Department statement.

The U.S. attorney general's office explained then that the plea "further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women."

That plea was just the beginning of the pharmaceutical behemoth's legal ramifications.

More than 200 federal Zofran lawsuits have been consolidated before a single federal judge in Massachusetts for uniform pretrial proceedings. When it began transferring Zofran lawsuits to one multidistrict litigation court in October 2015, the U.S. Judicial Panel on Multidistrict Litigation wrote this: "These actions share factual questions arising from allegations that Zofran and its generic equivalent, a prescription medication for the treatment of nausea, causes birth defects in children when their mothers ingest the drug while pregnant."

Zofran lawsuits continue to be filed in both federal and state courts, and the Zofran lawyers at Reich & Binstock are taking on cases in which parents and children harmed by Zofran are entitled to compensation. The law firm takes cases from all 50 states.

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