Zofran is a brand name prescription drug that, through a tablet or injection, alleviates nausea and vomiting. It is known generically as ondansetron and works by blocking the chemicals produced in the body that cause those symptoms. It was branded by the British pharmaceutical GlaxoSmithKline as Zofran in 1991, and thus approved by the U.S. Food and Drug Administration (FDA) for the treatment of nausea and vomiting in cancer patients dealing with the effects of surgery, chemotherapy or radiation.
Since its inception, Zofran has become widely and unlawfully prescribed off-label to pregnant women suffering from nausea and vomiting associated with pregnancy (NVP.) This reappropriation of the drug caused an uproar that culminated in various international studies concerning the drug’s correlation with a rise in birth defects and other side effects. In 2011, a study sponsored by the U.S. Centers for Disease Control and Prevention (CDC) and led by the National Birth Defects Prevention Study determined that Zofran, while taken during pregnancy, may double the risks of certain birth defects.
Potential Zofran Side Effects
Birth Defects are the main concern with the use of Zofran. To make matters worse, NVP often correlates with the first trimester of pregnancy, a decisive period in the development of an infant.
- Heart Defects such as cardiac arrhythmia, a conditioned defined by a slow or fast heartbeat, is a potential risk for the infant, but also for the mother with prolonged use of ondansetron.
- Mouth Deformities like cleft palates and lips were determined to be the most common birth defect amongst Zofran side effects according to the the National Birth Defects Prevention Study.
- Musculoskeletal Anomalies like clubfoot have been reported in some cases and are on the list of possible birth defects that are currently being studied in relation to ondansetron.
- Jaundice is a condition wherein the body’s blood bilirubin levels are out of balance, and is characterized by a yellow pigmentation of the skin. Jaundice has been reported by a minimal amount of the cases dealing with ondansetron.
- Craniosynostosis is a condition where an infant is born with an abnormally shaped skull that obstructs the proper development of the brain. This condition can lead to problems with vision and motor skills, as well as mental impairment.
- Additional Side effects that have been reported from patients in correlation with the use of ondansetron are: constipation, difficulty with breathing and swallowing, body swelling, rashes, anxiety and dizziness.
The FDA has not banned Zofran, because it was not specifically designed or approved for use during pregnancy, but they have acknowledged that taken as such it can potentially lead to serious birth defects. Furthermore, the U.S. Department of Justice sued GlaxoSmithKline in 2012 for promoting unapproved uses of many of their drugs, amongst those was Zofran. The pharmaceutical plead guilty to the criminal charges including fraud and failure to report safety data, and was forced to pay three million dollars in fines. Zofran side effects are many and vary in severity, but the drug is still lawfully prescribed to treat the side effects of some cancer treatments. Every doctor has a legal and professional duty to warn patients about the risks of prescribed medication.
If you, or anyone you know is suffering because of this drug, please contact Charnas Law Firm, serving the New York and Boston areas. 866-980-4499, or email us at firstname.lastname@example.org