Zofran, Pregnancy, and Birth Defects
Zofran, also known by its generic name Ondansetron, is a drug prescribed to treat nausea and vomiting for patients experiencing side effects caused by certain treatments and medications. In particular, the drug helps alleviate nausea and vomiting caused by surgical procedures and cancer treatments like chemotherapy and radiation therapy. It was manufactured by GlaxoSmithKline in the 80s, and was approved by the Food and Drug Administration (FDA) in the early 90s.
The drug primarily works by inhibiting the production of serotonin, which triggers a particular area in the brain that is responsible for causing nausea and vomiting symptoms. This is why Zofran is called a serotonin blocker or serotonin antagonist. While it was originally intended to help surgical and cancer patients, it is considered to be helpful in alleviating nausea and vomiting caused by stomach issues such as gastroenteritis and even pregnancy.
The use of Zofran for pregnancy related sickness is what the medical community calls “off-label use”. It means that the drug is being prescribed to patients outside what it was originally intended and approved for by the FDA. Zofran’s off-label use became particularly rampant among pregnant women when GlaxoSmithKline had, according to William Kherkher, started promoting it safe for this very use.
Even though Zofran proves to be a highly effective drug, pregnant women should remain cautious about taking the drug. Unfortunately, there have been reported cases linking the use of Zofran to birth defects in infants. In recent years, several lawsuits have been filed by women who claim that their morning sickness regimen is actually the cause of their child’s life-threatening illnesses.
Just in 2013, the FDA issued a statement raising potential safety issues regarding the drug. However, scientific research about the drug’s pregnancy risks is often conflicting. In 2012, a study conducted by Motherisk found that the Zofran should no longer be prescribed to pregnant women. It recommended taking extreme caution, considering there is very little evidence to prove that it’s completely safe for consumption during pregnancy.
The use of Zofran during pregnancy may result in the following issues for the unborn child:
- Congenital heart defects
- Mouth deformities such as cleft lip and cleft palate
- Muscolo-skeletal abnormalities
If you suspect that Zofran might have caused heath issues your child is currently experiencing, do not hesitate to seek legal counsel and seek out further information. Zofran birth defect lawyers could help you learn which options are available for you.