Dangers of Zofran
Zofran is a popular prescription-based medication that’s approved for use by cancer patients and those undergoing treatments such as chemotherapy and surgery. Zofran helps patients control nausea and vomiting, a typical side effect of cancer treatment. Yet, doctors have also been prescribing the drug to pregnant women to help control morning sickness, despite studies showing that Zofran increases the risks of babies developing birth defects.
FDA Warning Against Zofran and Serotonin Syndrome
In 2013, the FDA issued a warning about the dangers of taking Zofran while pregnant. Women who take the medication are a heightened risk of developing serotonin syndrome, an extremely dangerous medical condition that occurs when taking drugs that increase the amount of serotonin that the body produces.
Study on Zofran and Birth Defects
In the December 2014 issue of American Journal of Obstetrics and Gynecology, Dr. Gideon Koren, a Canadian pediatrician and clinical pharmacologist, published his findings on a study of 900,000 Danish women who took Zofran while pregnant, and the drug’s effects on infants.
According to the study, in the U.S. alone, Zofran off-label use for morning sickness reached 110,000 prescriptions by the end of 2013. Since then, the numbers of birth defects has risen in women who took the medication while pregnant.
Koren reported that the most common birth defect associated with Zofran was heart malformations. Per the study, infants exposed to Zofran have a “2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations.”
Other Birth Defects Associated With Zofran
Along with heart malformations, a number of additional birth defects have been associated with Zofran use while pregnant, including:
Cleft lip and cleft palate
Musculoskeletal birth defects
Hearing and vision problems
Hearing and vision problems
Amniotic band constriction
Spina Bifida, and more
GlaxoSmithKline and Zofran Lawsuit Information
GlaxoSmithKline (GSK), the makers of Zofran, are accused of not doing enough studies to ensure that Zofran was safe for humans before putting the drug on the market. The company is also accused of offering “kickbacks” to doctors in order for them to prescribe Zofran as off-label use for morning sickness.
This isn’t the first time GSK has been accused of shady business practices. In fact, in 2012, the company paid $3 billion to the U.S. government in a fraud settlement, after it was determined that GSK misrepresented several of its medications.
GSK promoted three of its antidepressant medications (Avandia, Paxil, and Wellbutrin) for unapproved uses, and failed to report required safety data about its top diabetes medication. Prosecutors in the case against GSK stated that the drug manufacturer attempted to win over doctors and get them to prescribe medications as off-label use by offering them free trips to destinations such as Bermuda and Jamaica. The company also offered many doctors free spa treatments and hunting trips.
The company is now facing mounting Zofran lawsuits as more and more families come forward after their babies were born with birth defects. Some women’s babies had birth defects so severe that they were forced to terminate their pregnancies.
If you or a loved one took Zofran while pregnant, there is help available. For information and assistance with Zofran lawsuit information, please visit Zofran Lawsuit Guide.