What is an Zofran?
Zofran is an anti nausea drug that most pregnant women use to get relief from morning sickness. However, women who take this drug may be unaware of the major side effect that can be linked to hundreds of birth defects in children. These are mainly heart defects that include heart craniofacial defects or septal defects, and also in some cases cleft palates kidney malformations.
Zofran is an ondansetron that is a prescription drug that was approved by the FDA in 1991 to prevent nausea and vomiting that is caused due to surgery, chemotherapy for cancer and also radiation therapy. However, many doctors have started prescribing this drug for off-label purposes like treating stomach problems in children and morning sickness in pregnant women.
The treatments of cancer cause vomiting and nausea as they cause some specialized cells that are present in the intestinal lining to release serotonin that is a neurotransmitter. Zofran is an antiemetic medication that works by blocking serotonin from entering into the areas of the brain that are responsible for triggering nausea and vomiting.
Types of Zofran
Zofran can be found in different forms such as
- Zofran injections, 2mg/L this was the first types of this drug approved in 1991.
- Zofran Tablets, 4 mg and 8 mg these were later approved in 1992
- Zofran Premixed injection, 32 mg this was approved in 1995 but was recalled in 2012
- Zofran Oral Solution, 4 mg/5ml this was approved in 1997 but then discontinued in 2016
- Zofran Orally Disintegrating Tablets 4mg and 8mg this drug was approved in 1999
There are certain drugs that can increase the risk of serious side effects when they are used in combination with Zofran. These drugs include
- Rifampin, Phenytoin, and Carbamazepine
- SSRIs and SNRIs
- Alfentanil and atracurium
- Also any drugs that affect the cytochrome P-450 drug metabolizing enzyme
Side effects of Zofran
The serious side effects that are linked with zofran are
Serotonin Syndrome this occurs when there is too much serotonin present in the body. This can be life threatening and the symptoms include irregular heartbeat, agitation, dizziness, tremor, seizures, unconsciousness and very high fever.
- QT Interval Prolongation
- Zofran affects the electricity in the heart, this can cause erratic heartbeats which can be very fatal for the individual
Other serious side effects can include
- Blurred vision and vision loss
- Shortness of breath
- Excessive sweating
- Loss of consciousness
- Chest pain
- Hives or rashes
There are also minor side effects related to this drug that are as follows
Safety Communications and Recall of Zofran
As mentioned before the 32 mg intravenous dose of Zofran was recalled in 2012 due to concerns that this drug triggered QT interval prolongation. Before this drug was recalled the FDA sent out a safety communications with the intensions of alerting the general public about the cardiovascular safety concerns of this drug
In 2011, the FDA made changes in the label of the drug and required that the manufacture of this drug conduct through QT studies to assess the potential of this drug to prolong the QT interval.
The agency also advised that the patients with eAs lectrolyte abnormalities should go for regular monitoring of ECG.
Although this drug was mainly intended for use in patients who suffered from nausea and vomiting some doctors prescribed these drugs off-label to pregnant women who suffered from severe morning sickness. It was found that there were several birth defects in babies whose mothers had taken Zofran for morning sickness. These birth defects included
- Cleft Palate
- Cardiac Septum Defect
- Congenital Heart Defects
- Kidney Malformation
- Mental problems
- Hearing loss
- Vision problems
- Abnormal blood pressure
- Stomach problems
- Cleft lip
- Club foot
- Webbed toes
- Skull deformities
Due to these reasons there was an increase in the number of mothers who were filing lawsuits against Zofran.