The popular medication Zofran is intended for use either on its own or with another medication to minimize nausea and any vomiting often produced as an unfortunate side effect of radiation therapy or chemotherapy for cancer. It can also be used for the purpose of treating or preventing feelings of nausea or vomiting after a surgical procedure. Medical professionals have also been known to prescribe Zofran to pregnant women as a treatment for morning sickness. The drug prevents nausea by blocking natural serotonin that is typically a trigger for vomiting.

There is just one problem with the potential uses for Zofran detailed above, the Food and Drug Administration (FDA) failed to approve its use by pregnant women.

It has come to light that the possible side effects of Zofran include a serious risk of birth defects if a mother has been prescribed the medication to combat morning sickness. Reports indicate cases of:

• Jaundice
• Heart defects
• Mouth deformities
• Kidney malformation
• Musculoskeletal issues

Records exist indicating that the medication manufacturer, GlaxoSmithKline, may have known twenty-three years ago that the drug presented a serious risk to developing fetuses because the drug passes through the placenta. Despite being in possession of this information, the company responsible for the production of Zofran continued to market it ”off-label” to women from the early 1990’s until April 2015.

Why should I file a court case as a former Zofran user?

• The manufacturer failed to warn consumers about potentially dangerous side effects.
• The company failed to evaluate fully all data and safety information regarding Zofran for use by pregnant women.
• GlaxoSmithKline offered the drug as a safe treatment for morning sickness even if it was not approved by the FDA.
• GlaxoSmithKline had a duty to consumers to verify the medication was safe before offering it to the public but failed to determine all risks before selling it.

Zofran was NEVER approved for use by any pregnant woman, and lawsuits do exist accusing GlaxoSmithKline of offering the medication to expectant mothers as well as directly paying medical professionals to prescribe it.

If you are concerned that “off-label” use of Zofran during pregnancy could be the cause of any complications, call Frank Charles Miranda, P.A. today for a consultation at 813-666-8332.