Zofran has been prescribed to pregnant mothers to treat morning sickness for many years, but the drug has a potentially serious downside that few mothers-to-be realized when they were taking it. The drug has been linked to potentially fatal birth defects.
In recent months the number of lawsuits brought by mothers who took Zofran in the first trimester of pregnancy and later had a child with a birth defect such as a heart malformation of an oral cleft, has been growing rapidly.
Zofran is manufactured by GlaxoSmithKline, a massive pharmaceutical company that was fined $105 million last year over charges in Texas and other states that it illegally promoted drugs. A $3 billion settlement in 2012 made by Glaxo resolved allegations that GSK promoted certain forms of Zofran off label in that drugs only approved only for post-operative nausea, were used for the treatment of morning sickness in pregnant women.
Now it is facing claims that it marketed Zofran to pregnant women without studying the potential risks of the drug to unborn children. Here are some basic facts about the drug:
- What is Zofran?
Zofran is also known by the genetic name ondansetron. It’s a prescription medication that can be prescribed for nausea and vomiting. The drug has been used to alleviate the feelings of nausea associated with surgery, chemotherapy, or radiation. More recently women have used it to counter morning sickness.
- How Does Zofran Work?
The drug blocks the chemicals in the body that cause nausea and vomiting. 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?
Around 80 percent of pregnant women suffer from morning sickness, and about 1 million pregnant women are exposed to 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?The U.S. Food and Drug Administration (FDA), states taking Zofran while pregnant can potentially lead to serious birth defects. The FDA has linked the drug to abnormal heart rhythms. Despite the warnings, the drug is still being prescribed to women who experience morning sickness. Alarmingly, since morning sickness is most commonly associated with the first trimester of pregnancy, women prescribed Zofran have been taking it during an infant’s most crucial development period. Although the FDA has issued warnings about Zofran, it has stopped short of preventing Zofran from being prescribed. However, doctors now have the legal duty to inform all pregnant women about the risks associated with Zofran before they prescribe it.
What Are the Most Common Birth Defects Associated with Zofran?
- Musculoskeletal anomalies
- Mouth deformities
- Heart defects
How Much Research Has Been Done into Zofran’s Side Effects for Pregnant Women?
An initial study carried out by Statens Serum Institut in Copenhagen found no evidence that the fetus was placed at risk by the use of Zofran during early pregnancy. That study was based on a sample of 600,000 women.
However, another Danish study, which was based on research into 900,000 pregnant women who took Zofran, suggested there was a two-fold increase in infant heart defects.
Lawsuits Against Glaxo
Former users of Zofran are now filing large numbers of lawsuits against GlaxoSmithKline. The claims point to court documents that show 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.
Morning Sickness and Zofran are a huge issue, if your baby was harmed after you took Zofran, you should call our Houston Personal Injury Lawyers at 713-888-8888 or toll-free at 888-630-9898.