Taking Zofran during pregnancy may cause birth defects including cleft palate or cleft lip and heart defects such as atrial septal defect (ASD) and ventricular septal defect (VSD).
Why File a Zofran Lawsuit?
A Zofran lawsuit can help in two important ways.
First, filing a Zofran lawsuit can help you get money to compensate your child for your child’s injuries.
Second, filing a Zofran lawsuit can help you stand up for all the women and expectant mothers you know. Women should have been warned by the drug manufacturer of the potential risks to your unborn child before taking Zofran.
What is Zofran, Exactly?
By blocking serotonin, a natural substance in the body, Zofran is able to block the body’s tendency towards nausea and vomiting, too. Unfortunately, for women who were prescribed Zofran to fight morning sickness, the gift of fighting nausea might have come with a very heavy price tag.
Typically, pregnant women are prescribed Zofran in its oral tablet form to be taken once or twice per day or as an oral solution. Zofran may also be given to patients through injections.
Zofran is manufactured by GlaxoSmithKline, a pharmaceutical company we have fought in court several times and recently settled with in a high-profile Avandia case. Zofran’s most common generic name is Ondansetron.
What Are the Top Associated Risks?
Taking Zofran during pregnancy may cause babies to be born with “birth defects” including:
- Cleft palate or cleft lip
- Heart defects – specifically septal heart defects like atrial septal defect (ASD) and ventricular septal defect (VSD)
Early studies showed little to no risk of side effects with Zofran. Yet as time went on, it turned out that these early studies may have been flawed and more research was, in fact, needed.
Now we’re learning the real facts behind Zofran, thanks in part to the mothers who are speaking up after their children were allegedly hurt by the drug.
A study published in the December 2014 issue of American Journal of Obstetrics and Gynecology helps to show the associated risks of taking Zofran during pregnancy, worryingly stating:
“Presently, 97.7% of prescriptions for the treatment of nausea and vomiting in pregnancy in the United States are with medications not labeled for use in pregnancy, not indicated for nausea and vomiting in pregnancy, and not classified as safe in pregnancy by the Food and Drug Administration. The use of ondansetron(*) for nausea and vomiting in pregnancy has increased from 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, despite unresolved issues regarding fetal safety and Food and Drug Administration warnings about serious dysrhythmias […] there is no reason for women to be exposed to a drug of unproven maternal and fetal safety.”
(**) Dysrhythmias = Disruptions of rhythm, i.e., abnormal cardiac rhythm.
The vast majority of anti-nausea medications prescribed to pregnant women have not been shown to be safe to use during pregnancy and while the use of Zofran during pregnancy has more than doubled in the last seven years, it’s safety is in serious question.
The FDA has identified Zofran causing serotonin syndrome as a “potential safety issue” during pregnancy. The FDA is continuing to evaluate the issue to determine the need for any regulatory action.
In addition, the FDA has NOT formally approved Zofran for use during pregnancy. Which means that any pregnant woman who takes Zofran during her pregnancy is doing so “off-label.” Unfortunately, for far too many women, they were not made aware of the potential risks.
The fact that Zofran may be prescribed to women off-label to treat morning sickness is a big deal, as pregnancy is a known time in a woman’s life where health complications and risks can increase, for both the mother and her baby.
Sadly, Zofran’s drug manufacturer, GlaxoSmithKline, may have a history of promoting drugs for off-label uses. Case in point: 2012, when the U.S. Department of Justice filed a lawsuit against the pharmaceutical company for promoting several of their drugs for off-label purposes. The lawsuit was eventually settled for $3 billion.
The rules about off label drug marketing are pretty simple: Doctors are allowed to prescribe drugs for off-label purposes, but drug manufacturers and marketers are NEVER allowed to market drugs for off-label purposes. This is because some doctors might have patients with rare symptoms or other sensitivities that might benefit from an off-label prescription; but drug manufacturers and marketers, who are responsible for drugs that may be taken by countless patients across the country and even across the world, have to be able to prove that a drug is safe for its intended patient group. It’s a strict rule that is in place to keep all patients safe. And when it’s broken… patient safety is seriously jeopardized.
Interestingly, GlaxoSmithKline itself has even stated that Zofran has not been tested in pregnant women. But that did not stop them for promoting the drug for off-label purposes, potentially endangering the health of countless pregnant women and their babies.
Every mother knows that rules are made for a reason. We only wish more pharmaceutical companies, and especially GlaxoSmithKline, would have followed the rules about what they can and can’t market. Now, we’re fighting on behalf of these mothers to make sure that more babies aren’t hurt by Zofran in the future.
It’s an unthinkable reality: A drug that was not approved for use during pregnancy, and that had no data regarding its use during pregnancy, prescribed to countless mothers across the country.
If you or a mother you know had a baby born with a birth defect like cleft palate or a heart defect and you took Zofran during your pregnancy, we encourage you to call one of our Zofran lawyers as soon as you can at 866-520-2755 or complete our contact form. We are proud to be helping as many mothers as we can fight back against this injustice… and help protect their families.