New study questions earlier safety data regarding the consumption of Zofran (Ondansetran) during pregnancy as a treatment for nausea and vomiting.
A recent study published in the American Journal of Obstetrics and Gynecology contradicts the earlier findings regarding fetal safety when Zofran prescribed to pregnant mothers. The findings of the new study indicate that Zofran may increase the risk of serious birth defects and possibly cause injury to the mother, Southern Med Law reports.
Zofran Side-effects suffered by babies include:
- Atrial septal defect (hole in the heart)
- Cleft lip
- Cleft palate
- Fetal growth restriction
- Heart defects
- Heart murmur
- Kidney malformations
- Mouth deformity
- Musculoskeletal defects
- Serotonin Syndrome
- Ventricular Septal Defects (Hole Between The Lower Chambers Of The Heart)
Ondansetran, brand name Zofran, is manufactured by GlaxoSmithKline, and approved in 1992 by the U.S. Food and Drug Administration as treatment for nausea and vomiting for cancer patients. The drug is a 5-HT3 receptor antagonist that affects serotonin levels in the brain. Physicians however, have been increasingly using the drug to treat NVP, which is nausea and vomiting in pregnant women.
Southern Med Law is committed to protecting the rights of all individuals injured by dangerous drugs, defective medical devices, and harmful products, due to companies putting profits before people. A dedicated leader in medical injury litigation, Southern Med Law has successfully taken on some of the largest medical companies on behalf of their clients. Southern Med Law now offers free legal consultations to those who have had babies with birth defects allegedly due to the use of the anti-nausea drug Zofran. Call 1-205-547-5525 or fill out our online form located on the www.southernmedlaw.com website.
Research Shows Increased Risk for Zofran Birth Defects
In January 2012, a study conducted by the Center for Birth Defects Research and Prevention discovered a twofold increased risk for the cleft palate birth defect as a result of Zofran treatment in the first trimester of pregnancy. The study also looked into the use of this drug and other non-cardiac birth defects.[ http://www.ncbi.nlm.nih.gov/pubmed/22102545]
In February 201,3 a study was published that detected a twofold increase in congenital heart defects as a result of the use of Zofran during the first trimester of pregnancy. The study also showed a 30% increased risk of congenital malformation among women who were prescribed Zofran. This was mostly a result of the increased prevalence of heart deformities. The fetus also faces potential risks of cardiac arrhythmias and serotonin syndrome when the mother is prescribed Zofran.
Studies Show Possible Zofran Risks to Maternal Safety
In June 2012, the Food and Drug Administration (FDA) issued a warning of possible serious cardiac output prolongation and Torsade the Pointe among patients on Zofran. The FDA now requires strict workups of patients using Zofran, in order to rule out long OT, congestive heart failure, electrolyte imbalance or those patients taking concomitant medication that extends the OT gap. Concerning women suffering from severe NVP, they often display electrolyte abnormalities known as either hypomagnesemia or hypkalenia.
A life-threatening disorder resulting in over serotonergic activity in the brain known as serotonin syndrome has been reported with the concomitant use of 5-HT3 receptor antagonists including Zofran. The FDA announced in May 2013 that a potential safety issue was identified when they discovered patients taking 5-HT3 receptor antagonists, including Zofran, are at an increased risk for serotonin syndrome. The results were identified during the period January-March 2013 and the agency planned to investigate the link between the two more in depth.
Legal Help For Victims Of Zofran Birth Defects
Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made Southern Med Law an aggressive and effective advocate for those who were harmed due to dangerous and defective drugs. If you or a love one experienced injury during pregnancy or birth defects from Zofran, please contact the Firm today to learn more about your legal rights. You can arrange for a free, no obligation Zofran lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.