27/08

Evidence Mounting against Zofran as a Morning Sickness Treatment

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More evidence continues to mount against Zofran, a popular anti-nausea drug produced by drug behemoth GlaxoSmithKline. Zofran is frequently prescribed to women suffering from morning sickness and hyperemesis gravidarum during pregnancy. A recent study by Dr. Gideon Koren, the director of the Motherisk Program, highlighted the risk of taking Zofran and pointed out a number of conflicting studies that cannot rule out dangers to the fetus.

Dr. Koren’s most startling finding was the following:

The study of 900,000 Danish women in August 2013 found “2-fold increased risk of cardiac malformations with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations (birth defect).”

A 30% increase in birth defects? That is a deeply unsettling number. Lets take a look at the vomiting process in the body, the purpose of Zofran, how it works, and the evidence mounting against it.

 Area Postrema, or vomiting center – the area of the brain that controls vomiting

Vomiting is controlled by an area in the brain called the area postrema or, vomiting center. The area postrema plays a critical role in a number of autonomic functions performed by the central nervous system.

How do the “vomiting messages” get to the area postrema?

Serotonin is a neurotransmitter produced by the body. Serotonin delivers messages to serotonin receptors. In the case of nausea and vomiting, serotonin delivers the vomiting message to the serotonin receptors. The receptors then send the message to the area postrema, telling the body to initiate vomiting. This causes the body to experience nausea and trigger vomiting.

Simply, Zofran blocks the serotonin receptors and thus blocks the “vomit” message. As such, the area postrema never receives the message to vomit. As a result, the body doesn’t experience nausea or vomiting. Therefore, Zofran theoretically prevents nausea and vomiting.

What is Zofran?

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Zofran (ondansetron) is a prescription medication that is officially known as a “5HT3 receptor antagonist.” Zofran is an anti-emetic and is used to prevent or treat nausea and vomiting. Zofran is manufactured and sold by GlaxoSmithKline and was approved by the U.S. Food and Drug Administration (FDA) in 1991.

Zofran works by blocking the 5HT3 receptors that are found in the brain and gut. This prevents the nausea messages being sent from these areas to the area postrema.

Zofran use

Approximately 80% of pregnant women experience some type of nausea and vomiting during pregnancy. This is frequently referred to as “morning sickness.” Out of this massive number, over 1 million women consume Zofran every year, according to Dr. Koren.

A number of studies have implicated Zofran’s role in causing congenital malformations. Also recently, a 2014 study in Reproductive Toxicology reported a statistically significant increase in cardiac septum defects in children whose mother’s used Zofran during pregnancy.

Lawsuit against GlaxoSmithKline, the manufacturer of Zofran

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Amount the manufacturer of Zofran agreed to pay for failure to report safety of Zofran, among other drugs

The Department of Justice sued GlaxoSmithKline (GSK) for unlawful promotion and failure to report safety of a number of its drugs, including Zofran. GlaxoSmithKline pled guilty and agreed to pay $3 billion dollars in 2012 to settle the lawsuit.

Furthermore, GSK paid the settlement as part of its practice to give “kickbacks” to doctors who prescribed Zofran.

A simple Google search of “Zofran lawsuit” results in dozens of pending lawsuits and lawyers willing to represent aggrieved families against the company.

Conclusion

Studies continue to demonstrate the dangers of Zofran. More and more evidence continues to mount against this dangerous pharmaceutical.

A company pays $3 billion to settle a lawsuit.
Doctors are accused of getting kickbacks for prescribing it.
A a recent study says Zofran results in a 30% increase of birth defects.

Is it worth the risk?

Sources:

http://www.netdoctor.co.uk/cancer/medicines/zofran.html

http://www.helpher.org/blog/wp-content/uploads/2014/01/2014-Koren-Ondansetron-Safety-TDM.pdf

http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report

http://www.motherisk.org/

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