The subject of Zofran and birth defects is a complex, unhappy one. What began as a drug that was designed to help those dealing with nausea and other undesirable side effects from cancer treatments has become a controversial issue for U.K. pharmaceutical giant GlaxoSmithKline. Lawsuits and class action suits abound, with the main thread for all legal matters concerning Zofran alleging that the drug is responsible for numerous reported birth defects.
GSK is a company with operations in more than 115 countries. They generate somewhere in the neighborhood of 35-million dollars a year. While the massive company will likely survive any short-term or long-term scandals associated with Zofran and birth defects, there is no question that their reputation has been tarnished by this whole ugly history.
The story as it stands with GSK, Zofran, and the studies linking the drug to birth defects is one that illustrates the problematic elements to not only healthcare, but to the significant amount of influence and power pharmaceutical companies have.
Does Zofran Cause Birth Defects?
The first thing you need to understand about Zofran and its link to birth defects is that Zofran was indeed approved by the U.S. Food and Drug Administration as means of helping cancer patients deal with nausea. The drug was approved for use after treatment or surgery. The drug could be taken in the form of oral tablets, oral solutions, oral disintegrating tablets, or even as an injection for intravenous usage.
When used as prescribed, the drug can be quite effective. Zofran blocks 5-HT3, which are serotonin receptors on your vagal nerves, running from your stomach to your throat. They can also be found in your chemo-receptor trigger zone or CTZ in your brain.
The problem with Zofran wasn’t whether or not the drug could be helpful to those suffering from nausea/vomiting within their cancer treatments/surgeries. The problem emerged when the drug became an off-label treatment for nausea/vomiting found in pregnancy. While the main idea remains the same, the truth of the matter is that the considerations of a pregnant woman are extremely different from the considerations of someone who is seeking chemotherapy, surgery, or other forms of treatment for their cancer.
It was when someone decided that one form of nausea/vomiting was the same as another that problems began to emerge.
The Link Between Zofran And Birth Defects
While physicians are allowed to suggest drugs to treat something the drug was not initially designed for, they can only do this in the event that they feel the potential good of their decision outweighs the potential bad to a significant degree. Furthermore, manufacturers are not allowed to promote or market a medication for any use beyond what it has been approved to do through the FDA.
This is where things got a little dicey for GSK. In 2012, the company paid out some three-billion dollars to deal with allegations that their company had engaged in illegal/improper marketing of Zofran. Keep in mind that this was not the only drug GSK was accused of doing these things with.
Birth defects linked to Zofran use by pregnant women includes:
- Congenital heart defects.
- Cleft palates.
- Kidney malformations.
- Skeletal defects.
- Fetal growth restrictions.
- Spontaneous abortions.
Studies indicate that Zofran usage can increase the overall rate of birth defects by as much as thirty-four percent.
Meanwhile, the lawsuits continue. Considering other companies have been manufacturing generic variations, and keeping in mind that the marketing rights for Zofran have changed hands, who can say what the future holds. And don’t forget about Zuplenz, a similar drug that is currently being marked and sold within the United States.