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"What are the Potential Side Effects of Zofran?
Zofran, also known as Ondansetron, is a prescription medication that is
manufactured by the pharmaceutical company GlaxoSmithKline (GSK). Zofran1
was originally developed to help mitigate the effects of chemotherapy and
radiation that cancer patients often suffer from. This drug can effectively block
the actions of the body that trigger nausea and vomiting. In addition to being
used to treat nausea in cancer patients, it was also used and prescribed to treat
nausea in patients post-operatively.
Since its development, however, Zofran has also been used “off-label” to treat
women for morning sickness. Typically prescribed during a pregnant woman’s
first trimester, it has been given to millions of women across the country for
What Does “Off-Label” Mean?
The term off-label drug use2 has several meanings. It may involve prescribing a
currently available and marketed drug for a symptom or disease that the Federal
Drug Administration (FDA) has not approved, or it may involve prescribing a
marketed medication to a patient population, dosage, or dosage form (e.g.,
intravenously, orally, topically, etc.) that does not have FDA approval.
Zofran has been prescribed off-label to a patient population that the FDA has not
approved use for as there are not sufficient studies or tests that have been
conducted in the respective population to show that it is safe for this particular
How Does Zofran (Ondansetron) Work?
Zofran, a powerful anti-nausea and vomiting drug, belongs to a class known as
the 5-hydroxytryptamine receptor 3 antagonists that block the effects of
serotonin.3 More commonly referred to as 5-HT3 antagonists or setrons, this class
of drugs acts as receptor antagonists at a subtype of serotonin receptor found in
the vagus nerve and other areas of the brain. These receptor antagonists are
extremely effective in treating nausea and vomiting in patients undergoing
chemotherapy, radiation, or post-operatively to help with the side effects of
Drugs used for chemotherapy often create serotonin in the gut which causes
nausea and vomiting. With the help of these serotonin antagonists, the body is
able suppress nausea and vomiting by preventing serotonin from activating and
sensitizing the gut.4
The FDA and Zofran
Zofran first entered the U.S. market in 1991 and it was FDA approved for the
uses previously mentioned. In 2011, the FDA administered a warning about the
drug indicating that there had been links between Zofran use and QT interval
prolongation, or effects on the electrical activity of the heart.5 Shortly after, there
were also warnings regarding the increased risk of birth defects developing in
children whose mothers had taken Zofran during pregnancy. Among the most
universally known birth defects associated with the drug are cleft lip and cleft
palate, in addition to heart defects, including Atrial Septal Defect (ASD).6
There have been a number of studies regarding the drug’s potential effect on
pregnant women, but additional studies are warranted. The CDC has issued a
warning of the possible connection between Zofran use and birth defects, and
the FDA has continued to condone prescribing drugs off-label. However, many
people believe that more studies are needed in order to obtain a clear answer on
the risks associated with taking the drug during pregnancy.7"
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