Labeled as a Pregnancy Risk Category B drug, Zofran gives the impression of being a safe drug that poses no risk to humans. However, despite this label, many mothers have tragically discovered different results. While Zofran is hailed as safe for mothers to take, there is much evidence showing the contrary. GlaxoSmithKline (GSK) actually never proved the drug to be safe for pregnant women when it was first cleared for other purposes by the FDA back in 1991. With around 1 million pregnant women in the U.S. alone taking the drug each year, it is crucial that the truth about the risks of Zofran be made clear.
Studies Show Major Risk of Birth Defects
Numerous studies have been done to identify the risks for congenital birth defects and demonstrate the dangerous nature of Zofran. One study from 2014 even showed a 30% risk increase for major congenital malformations in children whose mothers had taken Zofran.
The Centers for Disease Control and Prevention also took part in a large control study in 2011 that showed a twofold increase in risk of cleft palate defects for the children of women who took the drug during their first trimester. Other studies have shown increased risk for cardiac problems in mothers.
Serious Side Effects Connected to Zofran
Some of the most well-known birth defects effects tied to Zofran include:
- Kidney Problems
- Musculoskeletal Issues
- Cleft Lip & Cleft Palate
- Abnormal Blood Pressure
- Hearing & Vision Problems
- Various Physical Deformities
- Stomach Issues
- Ventricular & Atrial Septal Defects
Women who have taken Zofran for morning sickness have also allegedly suffered from:
- Serotonin Syndrome
- QT Syndrome
- Chest Pain
- Blurry Vision
Government Issues a Recall for Zofran
While Zofran was never approved to be used for pregnant mothers dealing with extreme morning sickness, doctors have been prescribing the drug for this off-label purpose for years. Many believe this dangerous move has put countless mothers and children at risk and caused many preventable birth defects over the years.
Just in 2012, the Federal Drug Administration decided to issue a recall for the 32 mg intravenous dose of Zofran. They did so because there was significant evidence to suggest the potential risk for cardiac problems. Despite this, the oral versions of the drug were not addressed at all. As the serious side effects of Zofran continue to come to the surface, some type of action needs to be taken for those impacted.
Have you or a loved one taken Zofran and suffered concerning side effects? Do not wait to get counsel and support during this crucial time. Call the award-winning lawyers at Arnold & Itkin today.