Anti-Nausea Drug Linked to Serious Birth Defects
Zofran, also known as ondansetron, is a drug used to deal with the effects of nausea, mainly for patients who are undergoing chemotherapy. It has also developed popularity in recent years as an off-label treatment for women who are struggling with morning sickness. Unfortunately, the drug has recently come under fire for being linked to serious birth defects. In December of 2014, the Toronto Star released reports that at least 20 women from Canada who had taken Zofran for morning sickness had suffered serious adverse side effects.
Just some of the side effects linked to Zofran include the following:
- Infant Deaths
- Heart Defects
- Kidney Malformations
- Fetal Growth Restrictions
- Musculoskeletal Abnormality
One doctor has since stated that they believe Zofran is the cause for one baby being born with a deformity of their mouth, jaundice, a heart murmur, and two serious heart defects including a hole in the heart.
Off-Label Usage of Zofran
Zofran, which is made by GlaxoSmithKline (GSK), was developed in the middle of the 1980s and was later approved by the FDA in 1991, with an additional divisional patent being granted in 1996. However, the drug has since gained popularity for its "off-label" usage—that means that doctors are prescribing it for the treatment of conditions or age groups outside of its original approval. While there are no laws to prohibit doctors from off-label prescriptions, it can be a dangerous practice, especially because there is no oversight. Currently, the FDA has not approved the use of Zofran for the treatment of morning sickness, and there are no studies that have been performed to test its safety.
Studies Linking Zofran & Birth Defects
In 2013, a study was published that showed Zofran was associated with an increased risk of cleft palate. The next year, a study was published in the New England Journal of Medicine that stated there was no link between the usage of Zofran and birth defects. Six months later, however, the same data was reviewed by a separate team of researchers that found women who took Zofran while pregnant doubled the risk of giving birth to a child with a heart defect; the data showed a 30% increased risk of birth defects overall.
$3 Billion Paid by GSK for Illegal Marketing
In 2012, the United States Department of Justice ordered GSK (the maker of Zofran) to pay a fine for, among other things, using illegal marketing to promote some of its medicines. The drug company was also accused of giving kickbacks to doctors. GSK pled guilty to charges involving fraud allegations and failure to report safety data.
GSK paid a $3 billion fine. At the time, it was the largest healthcare fraud settlement in our nation's history.
Have you suffered from the use of Zofran?
If your child was born with a birth defect and you took Zofran during your pregnancy, we encourage you to contact our drug injury lawyers today. We have won billions of dollars in verdicts and settlements on behalf of our clients, including a record-setting $76.6 million verdict for pharmaceutical injuries caused by Johnson & Johnson. To take the first step in recovering the compensation you deserve, contact our Zofran lawyers as soon as possible.
Call (888) 493-1629 or fill out our online form for your free consultation.