Was Zofran Ever Safe
Enough for Baby?

M any moms may have thought that Zofran was safe to take while pregnant. That was never true. And the fault — it doesn’t rest on you. From cleft palate to congenital heart defects, the potential side effects associated with taking Zofran while pregnant are scary and severe. So why did the manufacturer never say that something like this could happen?

DEAR MOMS: Please know this was not your fault. You did not do this to your baby. And that’s why we’re here. 

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You Count Five Fingers, Five Toes.
& Then it Hits You.

Your first priority is always taking care of your child, we get that. We’re here — Hi! it’s us at A Case for Women! — to make this easier on you. Because if your child was born with birth defects after you took Zofran during your pregnancy, you may be able to file a lawsuit against the manufacturer. Yeah — we hear you, what a drag! What a big expenditure of time and energy, the two things no new parent has.

Yet: If your baby was hurt, you’re in a position to stand up for other babies, other moms whose precious child was or could be seriously hurt because of a pharmaceutical drug like Zofran. 

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While you may have thought, along with so many other moms, that taking Zofran during your pregnancy was absolutely safe for you + your baby, the truth is that Zofran was never even tested in pregnant women. By filing a Zofran lawsuit you’ll stand up for other moms and babies who are in jeopardy today. That’s a pretty big deal. 

Oh, and even though it’s not about the $, let’s not forget the fact that all of those surgeries, doctor visits and therapies cost money, and lots of it. We’re so happy to think the Zofran lawsuit could be useful to you, on many different levels. 

Zofran was approved by the FDA to help cancer patients suffering from nausea. However, Zofran’s manufacturer, GlaxoSmithKline, quickly found another audience, moms.

Sales boomed. Around 1 million pregnant women worldwide rely on Zofran or its generic version each year. GlaxoSmithKline made millions off of these women. The only problem?

Zofran was not approved by the FDA to treat morning sickness. We think GlaxoSmithKline should have been more upfront about the potential side effects.

We’re talking about: Cleft palate as well as congenital heart defects and cardiac malformations including atrial septal defect, or “hole in the heart.”

Sadly, these side effects may hurt babies so badly that they require constant care and supervision — for the rest of their lives, forever.

All of Your Love
Can’t Take Away
What Zofran Did.

This is How We Change That. >

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Can You Pinpoint the Problem? 
Zofran was NEVER approved by the FDA for use in pregnant women. However, it appears as if that didn’t stop GlaxoSmithKline from marketing Zofran as a safe treatment for nausea in pregnant women. What they did was market Zofran for “off-label” uses — which is not legal and not safe.

Just Look at the Studies. 
Multiple studies have found that women who take Zofran while pregnant may suffer from a dramatic increase in major congenital birth defects. So why did GlaxoSmithKline market Zofran so heavily to pregnant women? And why didn’t GlaxoSmithKline say that something like this could happen?

We Wish We Could Tell You
This Is a One Time Thing. 

Instead, GlaxoSmithKline knew about the “unreasonable risk of harm” to developing babies (due to the fact that Zofran passes through the human placenta) as early as 1992. There’s also evidence that GlaxoSmithKline misrepresented animal studies — showing Zofran was safe when in actuality results may have indicated otherwise.

And let’s not forget: 2012, when GlaxoSmithKline pleaded guilty to federal charges of fraud + illegal promotion of several drugs, including Zofran. To refresh your memory, they pleaded guilty (to the U.S. Department of Justice) to: 1. Criminal Behavior. 2. Misbranding some popular drugs. 3. Failing to report safety data for some drugs to the FDA.

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“We’d do ANYTHING for our babies. That’s not what this is about. This is about one simple fact: You should have been told the full truth about Zofran and what it could do to your baby.”
–Yours, A Case for Women.

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