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Zofran, generically known as ondansetron, is a popular anti-nausea medication. It is often prescribed to patients in order to prevent nausea and vomiting caused by surgery or by cancer treatments such as chemotherapy and radiation as well to treat morning sickness.
Although Zofran is not FDA approved to treat morning sickness, many doctors prescribe Zogran for this off-label (non FDA approved) use. While it is illegal for drug manufacturers to market their products for off label uses, it is not illegal for medical professionals to prescribe medication for off label uses.
In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.
The U.S. Food and Drug Administration labeled Zofran a Pregnancy Category B drug. The FDA has established 5 pregnancy categories to indicate to consumers a drug’s potential for causing birth defects if used during pregnancy.
For category B drugs, reproduction studies performed on animals have not demonstrated a risk to animal fetuses and no adequate and/or well-controlled studies exist pertaining to actual pregnant women.
None of these categories take into account the risk and effects of passing the pharmaceutical agents to a fetus. Since Zofran was originally labeled by the FDA as a category B drug, several Zofran pregnancy studies have been conducted looking at the effects of Zofran in thousands of births. Many of these studies reportedly show that Zofran may actually cause harm to a developing fetus.
Potential Zofran Birth Defects
Recent studies have show that potential Zofran birth defects include cleft lip or palate, heart defects, kidney defects, musculoskeletal defects, poor fetal growth, and in some cases, fetal death.
In 2013, a study was conducted looking at 900,000 births in a Danish birth registry. According to the data, there was a 30 percent increased risk of Zofran birth defects when the medication was used during a woman’s first trimester.
The data also demonstrated a doubled risk of heart defects in babies whose mothers took Zofran. An earlier study performed in 2012 by the Center for National Birth Defects Research found that the risk having a baby born with a cleft palate was increased by 2.4 percent.
Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”
Zofran Birth Defect Lawsuits
As studies and reports of Zofran birth defects become more widely known and more victims are filing Zofran lawsuits, these lawsuits will help victims pay past and future medical bills as well as compensate them for the pain and suffering they have endured due to taking the medication.
Zofran lawsuits will also help hold large pharmaceutical companies like GlaxoSmithKline accountable for their actions and will serve to remind these companies that they have a duty to disclose serious risks associated with their medications.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The birth defect attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual Zofran lawsuit or Zofran class action lawsuit is best for you. [In general, Zofran lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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Join a Free Zofran Birth Defects Class Action Lawsuit Investigation
If you or someone you know took Zofran while pregnant and had a baby with a birth defect, you or this person may have a legal claim. See if you qualify by filling out the short form below.
A Zofran birth defect attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.
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