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Popular morning sickness drug Zofran linked to birth defects

Morning sickness in the first trimester of a pregnancy can become so bad that you look for any remedy that allows you to get through the day. As an embryo starts growing rapidly the release of a hormone called human chorionic gonadotropin is believed to be the main cause. Pregnant woman are often underrepresented in medical research, so it can be difficult to fully evaluate and appreciate the risks from prescription medication.

GlaxoSmithKline, makers of the popular anti-emetic medication Zofran (used to prevent nausea and vomiting), also sold under the brand name Zuplenz and the generic names Odensatron and Odensatron Hydrochloride, are facing lawsuits that allege a link between drug use during pregnancy and serious birth defects. Zofran was originally developed to battle the nausea associated with chemotherapy for cancer treatment, but it was later proven effective for anesthesia-related nausea and vomiting as well.

The treatment of nausea and vomiting related to chemotherapy and in conjunction with surgery are the only two uses for this medication that have been approved by the federal Food and Drug Administration (FDA). That being said, it been prescribed "off-label" countless times to pregnant women suffering the impact of routine morning sickness or its much serious counterpart, a condition known as Hyperemesis Gravidarum. It's also been routinely given to elderly and pediatric patients suffering from gastroenteritis (viral stomach infections that cause nausea and vomiting) despite it not being proven more effective than medications approved specifically for that purpose.

Startling lawsuit allegations

Hundreds of lawsuits against GlaxoSmithKline (GSK) and co-defendant Novartis (who purchased GlaxoSmithKline's oncology division in 2015) allege that birth defects have been seen in mothers who took Zofran or its generic equivalent for morning sickness while pregnant. Any condition affecting an infant can be serious, but the ones allegedly linked to Zofran are particularly troubling, and include:

  • Underdevelopment of heart musculature
  • Lack of development of all four functioning chambers, heart valve defects and holes in heart tissue
  • Kidney problems, often leading to kidney failure or requiring dialysis
  • Cleft palate
  • Club foot

Did you take Zofran while pregnant?

Many of the cases against GSK and Novartis have been consolidated into multi-district litigation in the District of Massachusetts. Individual cases are also pending in courts around the country.

If you, or someone you love, may have taken Zofran or Odensatron while pregnant and now are coping to understand how birth defects will affect your baby, you may have a legal claim. Schedule a consultation to discuss your concerns with an experienced attorney so any potential link can be investigated.

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