Zofran contains ondansetron hydrochloride and is a generic medication manufactured by Glaxosmithkline(GSK). Zofran is mainly prescribed to treat nausea and vomiting in patients who are receiving chemotherapy or radiation therapy in cancer treatment or after the surgery. It affects the serotonin levels in the brain and was approved in the year 1991 to treat nausea and vomiting in cancer related cases. Since then doctors continue to prescribe it to treat nausea and vomiting for pregnancy (NVP).
Zofran has been used as an “off-label” treatment for pregnancy related to nausea and vomiting. Doctors are allowed to use drugs as off-label treatment if the hazard overshadows the benefits but drug companies cannot encourage or market medications for a use of this kind.
A study which was conducted earlier didn’t find any safety issues with Zofran, but as per the newer studies the results in the earlier studies were not accurate and the data was too less to get to a conclusion. Recent studies have clearly indicated that Zofran risks birth effects when used in pregnant women. GSK has paid $3 billion dollars to the department of justice to settle the Zofran lawsuits. Thousands of cases were filed against Zofran manufacturer GSK claiming improper marketing of Zofran and illegally encouraging the drug to treat morning sickness in pregnancy.
Side effects of Zofran-
Almost all medications have side effects and like any other medication Zofran might cause side effects. Although most of the time Zofran side effects would be soft or momentary but if any of the below symptoms occurs while taking Zofran, consult with your doctor immediately-
- fast heartbeat
- shortness of breath
- Decrease in the frequency of urination
- decrease in the urine volume
- difficulty with passing urine (dribbling)
- painful urination
- Arm, back, or jaw pain
- chest pain or discomfort
- chest tightness or heaviness
- decreased urine
- difficulty with breathing
- difficulty with swallowing
- dry mouth
- fast, pounding, or irregular heartbeat or pulse
- increased thirst
- loss of appetite
- loss of bladder control
- loss of consciousness
- mood changes
- muscle pain or cramps
- nausea or vomiting
- noisy breathing
- numbness or tingling in the hands, feet, or lips
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin rash, hives, or itching
- tightness in the chest
- total body jerking
- unusual tiredness or weakness
Additional Studies Needed
As talked about earlier, to authenticate the data already provided in previous studies more studies is needed on Zofran side effects. In the mean while If you come across any of the above mentioned symptoms always speak with your doctor regarding the prospective side effects of Zofran and any other drugs. Your doctor has the legal responsibility to inform you of any and all risks linked with medicines prescribed to you.
Though GlaxoSmithKline has paid $3 Billion as a settlement, but this doesn’t release GSK from accountability for Zofran drug injuries that may have occurred due to the use of Zofran. If a child or the mother was injured because the mother was prescribed Zofran during pregnancy, they may file a Zofran lawsuit and might be entitled to compensation for their losses.