Zofran Lawsuit Plaintiffs Point To Study Results Questioning The Safety Of Anti-Nausea Drug

December 30, 2015 – – ZofranLegal.com reports on studies which support allegations of plaintiffs involved in the Zofran birth defect lawsuits, suggesting that the anti-nausea drug may cause an increased risk for severe birth defects when exposed to babies growing in the womb through their mothers.

Zofran was manufactured by pharmaceutical conglomerate GlaxoSmithKline, and is a 5-HT3 receptor antagonist. It works to eliminate feelings of nausea by changing serotonin levels within the patient’s brain. It is also available in generic form under the name ondansetron.

In 1991, the U.S. Food and Drug Administration approved Zofran’s release to market, however, the approved it specifically to treat vomiting and nausea episodes in patients who had recently undergone chemotherapy, radiation, or anesthesia. Despite this very specific approval, GSK went on to market the drug as a morning sickness treatment to pregnant women and Ob/Gyns nation-wide. This is considered “off-label” marketing, and it led to much “off-label” prescribing by physicians.

Shortly after pregnant women began to use the drug for morning sickness, reports surfaced of babies being born to those women with severe or even fatal birth defects. As “off-label” Zofran prescriptions increased, so did the reports of birth defects.

In a study from December 2014 by Dr. Gideon Koren, which was published in the American Journal of Obstetrics and Gynecology, the drug appears to have been linked to dangers to the fetus. Another study done the year before this, which evaluated 900,000 Danish women, found a “2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations.”

Today, as lawsuits claiming exposure to Zofran has caused many children to develop birth defects, these studies are being given a closer look. The women involved report to have used Zofran during their first trimester, when morning sickness is most prevalent. Unfortunately, however, this is also a time when the fetus undergoes much of its initial heart, limb, and mouth tissue formation, and therefore a time when defects are able to develop.

The attorneys at Monheit Law are working to help anyone who may have given birth to a child with defects after taking Zofran. These women and their children could be entitled to legal action and significant compensation. In order to help ensure that everyone affected has this opportunity, the attorneys at Monheit Law are currently offering free legal Zofran consultations.

To request additional information or ask questions, please contact Michael Monheit, Esq., lead attorney at Monheit Law by calling (877) 620-8411.

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Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046

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