What is Zofran?
Zofran (Ondansetron) is the brand name of a drug marketed and manufactured by global pharmaceutical giants GlaxoSmithKline. It is used, primarily, for the prevention of nausea and vomiting following surgery and for cancer patients undergoing chemotherapy or radiation.
Off -Label Uses
It is also used “off-label” as a treatment for morning sickness in pregnant women, although it has never been approved for use in pregnant women.
Who is Arianah?
Arianah Reisen is a 2 year-old girl who was born with two “hole in the heart” defects. Her heart has enlarged to twice its normal size. She is scheduled to undergo open heart surgery next month. Her mother, Kylee Riesen, believes that Arianah’s condition was caused by the anti-nausea drug Zofran that she took during her pregnancy.
Why are GlaxoSmithKline being sued?
It is alleged that GlaxoSmithKline became aware of the Zofran birth defect risk in the 1990's but failed to warn expectant mothers and/or their doctors.
Can an anti-nausea drug really cause heart defects?
GlaxoSmithKline will argue that there is no proof that Zofran can or has caused birth defects but evidence suggests otherwise. They will also deny that they promoted its use "off-label."
Evidence - Zofran heart defects
At a 2013 meeting of the International Society of Pharmcoepidemiology, Jon T. Anderson, a researcher at the Copenhagen University Hospital, reported the results of a study of more than 900,000 births in Denmark. The report highlighted that women who took Zofran during the first trimester had a two- to four-fold increased risk of cardiac septal defects.
A 2013 study funded by the Centers for Disease Control and Prevention, found that Zofran increased the risk of cleft palate by nearly two-and-a-half times.
A 2014 Swedish study, published in Reproductive Toxicology, found a more than 60% increase in risk of cardiovascular defects and a two-fold (double) increased risk of cardiac septal defects.
Evidence of GlaxoSmithKline promoting drugs for "off-label" use
"GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs." (Source)
One of those prescription drugs was Zofran. In short, GSK:
- marketed Zofran as a safe and effective treatment for morning sickness, despite the fact that it had not been approved for use in pregnant women.
- produced marketing materials that contained unsubstantiated or false claims of Zofran’s safety as a treatment for morning sickness.
- paid physicians kickbacks to prescribe Zofran to pregnant women suffering from morning sickness.
Why did GlaxoSmithKline conceal this information from doctors and patients?
Anyone want to hazard a guess?
I've been blogging about GlaxoSmithKline since 2006. I even wrote a book about them (The evidence, however, is clear, the Seroxat scandal). During my time writing about them they have threatened to sue me for defamation (or libel - I can't remember what terminology their British lawyers used) They failed in that attempt to suppress my opinion.
I have a passion for justice, especially where it involves children, infants and fetuses harmed or killed by drugs manufactured by GlaxoSmithKline. I strongly believe that GlaxoSmithKline are in the business of putting profit ahead of patient care, be that with antidepressant drugs they market and manufacture, (Paxil, Wellbutrin) or be that with their diabetes drug, Avandia or, as is in this case, an anti-nausea drug, Zofran, they market and manufacture.
I don't like GlaxoSmithKline, particularly their CEO, Andrew Witty. I don't like their American lawyers that defend them in cases, nor do I like their British lawyers who defend them in litigation in the UK. It has occurred to me during the past 9 years or so of writing this blog that it takes a person with a blackened heart to defend a company that is corrupt to the core (That's my opinion and it's not aimed at any particular law firm who defend GSK)
Ideally, I would love to see executives of GlaxoSmithKline behind bars for the crimes that they have committed. It's the executives who make the decisions that are fed down to the managers, who in turn feed that information to the GSK reps. This is normally the crux of any litigation brought against GSK. Their executives deny promoting the use of unsafe, untested drugs, the managers deny, the reps deny. Evidence used in these types of cases will show that they are lying...this is the evidence that the Judge, 9 times out of 10, seals away from the public. It's a real beef of mine.
I am aware that litigation is all about reaching settlements between both parties, I just wish Judges involved in these types of cases would allow the evidence to go public once these cases have been settled. It's almost like they (Judges) offer GSK some sort of consolation prize when they are forced to settle cases.
This one is for Glaxo and lawyers representing them. I hope the images of Arianah Reisen play havoc with your sleep patterns... although I doubt very much that any human suffering conjures up any form of emotion in you. Zofran has made GSK an obscene amount of money. Meantime, children, such as two year-old Arianah Reisen, have to go through life by laying down on operating tables having their hearts worked on by heart specialists - all because GSK wanted to make a profit. It's utterly shameful and it warrants a form of justice, not just compensatory payment, it warrants jail time for all of those involved in the suppression of Zofran causing harm to babies. That, however, is down to the man, or woman, who holds the gavel.
Rant over. Here's two year-old Arianah Reisen.
For more information on the birth defects caused by Zofran and to see if you, or someone you know, has a potential claim, visit the Baum, Hedlund, Aristei & Goldman, PC Zofran page, HERE.
Baum, Hedlund, Aristei & Goldman, PC are the good guys. They've won many cases against GSK in the past and genuinely have their client's interest at heart (Pardon the pun)