Zofran Not Approved for Use during Pregnancy
American Journal of Obstetrics & Gynecology (AJOG) studies have shown that more than 80 percent of women experience morning sickness during their first trimester of pregnancy. This is one reason why the drug has gained popularity as an “off-label” treatment recommended by physicians for patients suffering the debilitating effects of morning sickness. “Off-label” means that a drug is being prescribed for use in a way that is not consistent with its FDA-approved label.
Cardiac Abnormality Risk Results in FDA Warning
Studies link Zofran to increased risk of birth defects and dangers to the fetus in those women taking the drug. Other studies have found an increase in the risk of cardiac malformations in pregnant women.
The FDA issued a warning to health care professionals following results of a clinical study that linked Zofran with potentially fatal heart rhythms in patients given a 32 mg intravenous dose of the drug. As a result, the manufacturer, GlaxoSmithKline removed the 32 mg intravenous dose from the market.
Zofran Birth Defects
Birth defects have been associated with the use of Zofran. Studies on the use of the drug during pregnancy have revealed the following:
- Cleft palates and lips at birth occurring 2.4 times more frequently
- A high incidence of children born with club feet
- Twice as many births with heart defects
- Craniosynostosis — a condition in which there is not enough room for the brain due to a misshapen skull
- A 30 percent increase in birth defects when Zofran used in the first trimester
Zofran Effect on Serotonin Levels during Pregnancy
The FDA issued a warning in 2013 about an increased risk of serotonin syndrome in pregnant women using Zofran and other drugs similar to it. Side effects for women with serotonin syndrome may include:
- Birth Defects
- Muscle Rigidity
- Loss of Consciousness
- Tachycardia, or Rapid Heartbeat
Maker of Zofran Settles Fraud Allegations with Justice Department
The U.S. Department of Justice entered into a settlement with GlaxoSmithKline, the maker of Zofran, in satisfaction of civil and criminal claims in which the company agreed to pay $3 billion in penalties for promoting Zofran and other drugs for off-label uses and paying kickbacks to doctors for prescribing it.
Contact Mukerji Law Firm – Houston Zofran Attorneys
Lawsuits are being filed around the country against GlaxoSmithKline, the maker of Zofran, by women who gave birth to children with birth defects after taking the drug during their pregnancies. If you or someone you know took Zofran during pregnancy and suffered physical injury from side effects or gave birth to a child with a birth defect, you might be entitled to compensation. Contact Mukerji Law Firm today.