The birth defect research is obviously disturbing; however, Zofran (also technically known as “Ondansetron”) has also been linked with medical issues for the mother, including heart problems and a condition known as Serotonin Syndrome (SS). Let’s explore both of these issues.
Serotonin Syndrome and Zofran
If you recall, Zofran acts in part by changing the level of serotonin in the brain to reduce nausea and vomiting. Unfortunately, the body is not a simple lever system. In general, when you change one thing in the body (or in the brain), that action can have many downstream effects on you, physically, mentally and emotionally.
Serotonin is a critical player in neurochemistry. So when the levels of this neurotransmitter artificially change -- or when the biochemical machinery that uses and feeds back on serotonin is artificially changed -- the consequences can be pretty wide ranging.
WebMD defines the basics of Serotonin Syndrome this way: “Serotonin is a chemical produced by the body that enables brain cells and other nervous system cells to communicate with one another. Too little serotonin in the brain is thought to play a role in depression. Too much, however, can lead to excessive nerve cell activity, causing a potentially deadly collection of symptoms known as serotonin syndrome.”
The symptoms of SS can include fever, seizures and racing heartbeat as well as changes to emotional, cognitive and psychological changes. Perhaps unsurprisingly, some researchers have found that the SS-elated dangers of Zofran are elevated when a pregnant woman takes an SSRI anti-depressant along with the drug. (“SSRI” stands for Selective Serotonin Reuptake Inhibitor).
Such a finding, if confirmed, wouldn’t that be surprising because, as we just discussed, whenever you artificially alter the production or regulation of an essential neurotransmitter like serotonin, unintended side effects should probably be anticipated.
The Federal Drug Administration confirmed this risk in March 2013, linking Zofran as well as other so called “5-HT3 antagonists” with a heightened risk of Serotonin Syndrome.
The Department of Health and Human Services issued a “Pharmacovigilance Review” in February 2013 aimed to “evaluate the risk of developing serotonin syndrome (SS) with the use of a 5-THQ receptor antagonist [such as Ondansetron] when used alone or when used in combination with other serotonergic drugs.” The executive summary found (bold ours):
“Since approval of first 5-HD3 receptor antagonist, Zofran (Ondansetron), in 1991, the use of this class of medication as medic agent that become during chemotherapy and post-surgical situations in adult and pediatric patients. Ondansetron products accounted for over 99% of the serotonin 5-HD3 receptor antagonist utilization for years 2008 to 2012 made a search of the FAERS database in medical literature and identified 39 cases of serotonin syndrome related to the use of Ondansetron… There were three deaths… Based on the case review of the medical literatures suggesting several biologically possible explanations, there is potential for developing SS with the 5-HD3 receptor antagonist drug class when used alone or with other serotonin drugs in both sexes and in all age groups.”
To explore the possibility of bringing legal action right away to obtain compensation for Zofran-related birth defects, please call the experienced attorneys here at Marc Whitehead & Associates, LLP at (855)-423-3666. For more information regarding Zofran please download a copy of our free E-book, The Zofran Tragedy.