Attention Focuses on Potential Zofran-Related Birth Defects

Attention Focuses on Potential Zofran-Related Birth Defects

Posted By The Maher Law Firm || 16-Apr-2015

Our product liability attorneys in Orlando focuses on potential Zofran-related birth defects.

With "safe and effective" drugs now available to help women suffering from nausea and vomiting during pregnancy, "there is no reason for women to be exposed to a drug of unproven maternal and fetal safety" such as Zofran, Dr. Gideon Koren writes in a recent medical journal article.

The article by Dr. Koren, a Toronto physician who is considered one of the world's foremost authorities on medication use during pregnancy, was published in the December 2014 issue of the American Journal of Obstetrics & Gynecology.

Dr. Koren's call for changes in the way Zofran has been prescribed to pregnant women in the U.S. for treatment of morning sickness comes at a time when numerous product liability lawsuits are being filed against the manufacturer of Zofran, GlaxoSmithKline.

The lawsuits tend to claim that the children of mothers who used Zofran during the first trimester of pregnancy have suffered birth defects, including heart defects and cleft palates.

What Is Zofran?

The U.S. Food and Drug Administration (FDA) describes Zofran as a 5-HT3 receptor antagonist that blocks serotonin, which is a naturally occurring substance in the body that causes nausea and vomiting. The drug's generic name is ondansetron.

The FDA has approved Zofran to be prescribed to patients experiencing nausea and vomiting due to cancer chemotherapy and surgery.

However, as Dr. Koren points out in his article, Zofran has been increasingly prescribed for "off-label" use as a way to ease morning sickness in pregnant women.

According to Dr. Koren, prescriptions for that use rose from 50,000 per month in 2008 to 110,000 per month by the close of 2013 "despite unresolved issues regarding fetal safety and [FDA] warnings about serious dysrhythmias."

In fact, Dr. Koren points out, nearly 98 percent of the drugs prescribed to treat nausea and vomiting in pregnant women are not labeled for that use.

Study Finds Increased Zofran Birth Defect Risks

In his article, Dr. Koren discusses a study that was presented to the International Society of Pharmacoepidemiology in August 2013.

In the study, Danish researchers examined the records of 1,248 women who were prescribed Zofran (ondansetron) during the first trimester of their pregnancy. Out of those women, 4.7 percent gave birth to a child with a "congenital malformation." In contrast, only 3.5 percent of those women who were not exposed to the drug had children with birth defects.

According to the study, this meant that Zofran use by women in the first trimester of pregnancy created a 30 percent increased risk of birth defects in their children.

Our Zofran Birth Defects Lawyers Are Here to Help You

The Maher Law Firm currently is reviewing cases of birth defects in children who were born to women who took prescribed Zofran to treat morning sickness early in their pregnancy.

We believe that these mothers owe it to themselves and their children to have their case fully investigated and to understand their legal rights and options.

To schedule a free and confidential consultation, contact us today by phone or through our convenient online form.

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