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The Tragedy of Birth Defects Associated with Zofran During Pregnancy

This is Michael Brady Lynch, lead trial attorney for The Michael Brady Lynch Firm.

In my 18 year career, I have seen a lot of very sad cases of corporate misconduct in the pharmaceutical industry. The case of Zofran is by far one of the saddest.

A little background on Zofran:

Zofran works by blocking chemicals in the body responsible for nausea and vomiting. It can be taken orally, via a rapidly disintegrating tablet (ODT), or through injections. Pregnant women experiencing nausea and/or vomiting, however, are usually given the oral tablet, which typically starts around 8 mg per tablet, taken once or twice per day.

Zofran is also approved to treat nausea and vomiting in chemotherapy and surgery patients. Importantly, the FDA has not approved Zofran for pregnant women, but some doctors prescribe it “off-label” to treat severe morning sickness.

Zofran was developed by GlaxoSmithKline (GSK) and approved in the United States in 1991. The first generic versions were approved in 2006.

Zofran is a 5-HT3 antagonist that primarily acts on the nervous system. It works by blocking serotonin and increases gastric emptying, which helps reduce nausea and vomiting.

What is Morning Sickness?

Nausea and vomiting are estimated to affect 70-85% of pregnant women during the first trimester (weeks 6-12 of pregnancy), but hyperemesis gravidarum, or extreme morning sickness, only affects about 1% of all pregnancies

The condition is defined as uncontrolled vomiting requiring hospitalization, severe dehydration, nutritional deficiencies, muscle wasting, electrolyte imbalance, and weight loss of more than 5% of body weight — all of which pose serious health risks to both the mother and fetus.

Although no one knows yet exactly why pregnant women get nausea and/or vomiting, research suggests that more 50% of all pregnant will experience a bout of nausea during pregnancy. In instances in which nausea is severe and home remedies, such as consuming crackers and toast fail to work, women may be prescribed Zofran or similar medications.

It’s important to note that despite its potential risks, the FDA has not stopped Zofran from being prescribed. However, doctors have the legal duty to inform all pregnant women about the risks associated with Zofran prior to prescribing it. This may stem from the fact that Zofran isn’t created specifically for nausea and vomiting. Its main function is to treat those with cancer, as surgery, chemotherapy, and radiation can cause nausea. However, doctors are still legally allowed to prescribe the medication how they wish.

The most common types of birth defects that can potentially come from Zofran include:

Musculoskeletal anomalies
Mouth deformities
Heart defects

Because of the controversial side effects of Zofran, there have been numerous studies done, worldwide, in an attempt to gather more substantial results. For example, a 2011 study performed by a grant from the Centers for Disease Control and Prevention (CDC) states that Zofran doubles the risks of birth defects, while a Danish study, in which over 600,000 women taking Zofran were monitored, indicates that there isn’t a high risk. However, the same day the Danish doctors presented their evidence, another group of Danish doctors presented evidence that was the complete opposite, indicating that after following over 900,000 pregnant women who took Zofran, there was a two-fold increase in infant heart defects.

The harmful effects of Zoran have been increasingly in the news, including:

March 23, 2015 — Studies linking Zofran and a potential risk of birth defects have been growing for years, which adds evidence to lawsuits alleging that GSK knew or should have known about the risk.

March 19, 2015 – FDA warns about heart problems from Zofran, which could be very serious for pregnant women with electrolyte imbalances due to severe morning sickness.

March 18, 2015 — Using Zofran during pregnancy could increase the risk of having a baby with a heart defect by 62% and double the risk of “hole in the heart” defects, according to a study published in Reproductive Toxicology by Swedish researchers.

March 13, 2015 — A study published in Pediatric Emergency Care reports on two children who died from heart problems after being given ondansetron, the active ingredient in Zofran.

February 23, 2015 — A woman from Minnesota who had two children with heart defects after taking Zofran has filed a lawsuit (PDF) against GSK. Click here to read more.

February 19, 2015 — A lawsuit has been filed by a woman from Massachusetts who took Zofran during her first trimester of pregnancy and had a baby with three heart defects, facial deformities, webbed toes, and a number of other birth defects.

December 9, 2014 — The Toronto Star reports that heart defects and other birth defects have been linked to the use of Zofran during pregnancy. Click here to read more.

If you or a loved one was prescribed Zofran during pregnancy and gave birth to a child with a birth defect, please contact The Michael Brady Lynch Firm for a free, no-obligation case evaluation.

About the Firm: The Michael Brady Lynch Firm is a trial firm with a focus on pharmaceutical mass tort cases involving SSRI and Anti-Seizure Medication Birth Defects including Lexapro, Zoloft, Effexor, Prozac, Celexa, Paxil, Depakote and Topamax, Xarelto bleeding injuries, Mirena IUD, Actos Bladder Cancer, Testosterone heart attack and stroke injuries and medical device cases including DePuy Hip and Trans-Vaginal Mesh cases. Contact us today if you or someone you know has experienced side effects involving these products.  

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