Virginia and North Carolina Zofran Personal Injury Lawyers

Morning Sickness Drug Zofran is Linked to Birth Defects

The nausea drug Zofran has been on the market for more than 20 years and recently many mothers have discovered their babies suffered birth defects, like cleft palates, after the moms took this medicine during pregnancy. Cooper Hurley Injury Lawyers is currently helping families whose babies were born with mouth deformities caused by Zofran.

Zofran has been widely prescribed for morning sickness by obstetric doctors encouraged by the drug maker, but this was not the original approved purpose of the drug. The necessary research about its effect on pregnant women has not been carried out. This lack of safety information about Zofran has not stopped the manufacturer, GlaxoSmithKline, from marketing it to mothers-to-be and their doctors, without adequate warnings about the health risks to newborns.

What is Zofran?

The prescription drug Zofran (generically known as ondansetron) is approved to treat nausea and vomiting in patients following chemotherapy or surgery.

Zofran has also been prescribed to pregnant mothers to treat morning sickness for many years, but it has potentially serious downsides that most expectant parents not know of when they were taking it. The drug has been linked to potentially fatal birth defects.

How Does Zofran Work?

Zofran blocks the chemicals in the body that cause nausea and vomiting, which means it has proved attractive to pregnant women. It can be taken in an oral tablet or through injections. Pregnant women take it in the form of an 8 mg tablet, normally twice a day.

How Many Women are Taking the Drug?

Many women have been exposed to this drug. Approximately 80 percent of pregnant women suffer from morning sickness, and about 1 million pregnant women use Zofran or its generic version every year, according to Dr. Gideon Koren, who is associated with The Motherisk Program, The Hospital for Sick Children and the University of Toronto, Canada.

What Are The Warnings over Zofran?

In 1999, the U.S. Food and Drug Administration (FDA) sent a warning letter to the drug maker Glaxo for its failure to inform patients of Zofran's potential risks.

In December of 2012, the FDA announced a partial Zofran recall due to the heart rhythm problems associated with the medication. The recall only affected the 32 mg, single intravenous dose, the form generally used to prevent chemotherapy-induced nausea and vomiting.

The FDA has linked the drug to abnormal heart rhythms. Notwithstanding these warnings, the drug is still being prescribed to women who experience morning sickness. Morning sickness is usually associated with the first trimester of pregnancy. Alarmingly, expectant mothers who are prescribed Zofran have been taking it during an infant’s most crucial development period.

What Are the Most Common Birth Defects Associated with Zofran?

  • Mouth deformities like cleft palates.
  • Potentially deadly heart defects;
  • Musculoskeletal anomalies;
  • Jaundice;

Why the Use of Zofran in Pregnancy is Unapproved

The FDA has never approved Zofran, which was intended for use in cancer patients, for the treatment of morning sickness in pregnant women. However, GlaxoSmithKline has promoted the use of Zofran off label to doctors and expectant mothers, with inadequate research about its side effects during pregnancy.

In 2012, Glaxo pleaded guilty to federal charges of fraud as well as illegal promotion of many of its drugs, including Zofran, and paid $3 billion to the government as part of the legal settlement.

Lawsuits Against Glaxo

Large numbers of lawsuits are currently being filed against Glaxo by mothers who claim the drug caused birth defects in their children. The claims point to court documents that appear to show that as long ago as 1992, the British drug company knew that Zofran presented an “unreasonable risk of harm” to developing babies because the drug passes through the human placenta.

If your child has been harmed because you took Zofran for morning sickness, contact our experienced dangerous drug lawyers. We will provide you with experienced representation and make sure your claim is properly handled among the others in the mass tort litigation. Call us at 757.455.0077 or toll free at 866-455-6657 for a free consultation.