Bethpage, NYWhen Laura’s son was born with hypospadias, she had no idea that the birth defect could be caused by Zofran. “If nothing comes of my Zofran complaint I want to tell my story to help prevent this happening to another child,” says Laura.
Doctors told Laura only that hypospadias is a birth defect - they didn’t discuss possible causes. After some online research, she discovered that hypospadias can be genetic, hormonal or even environmental. Or a side effect of a variety of drugs, including Zofran. Because Laura took the anti-nausea drug during her entire pregnancy, she suspected the latter. And reading similar complaints from distraught parents made Zofran even more suspect.
Hypospadias is a common birth defect, occurring in 1 out of 200 males. The urethra, which forms during weeks 8-14 of pregnancy, forms abnormally and is not at the top of the penis. Amanda took Zofran to help treat morning sickness during her second trimester, which is from week 13 to the end of week 26.
“I don’t know if I can put my son through another surgery,” said Amanda.
“He is three years old and still having problems: he says it hurts. I’m scared about putting him through another surgery in case it doesn’t get corrected again.”
Laura took Zofran during her entire pregnancy. “Soon after my son was born, my pediatrician and urologist advised that he have surgery right away,” says Laura, “but we won’t know until he is potty-trained if it was a success. Of course I don’t want him to have another surgery. I’ve been a mom for eight years and not knowing is a whole new fear. Even anesthesia is worrisome because he is so young.”
Laura has two other children who were born with heart murmurs - she took Zofran during all three pregnancies, but for a shorter time with her first- and second-born. “My daughter has a cleft just above her butt that looks like a dimple. The doctors had to make sure there were no openings at the bottom of her spine,” she adds. “Thank god I didn’t take Zofran for any longer - she may have been born with spina bifida.”
A recent study in Obstetrics & Gynecology (April 2016) concluded that ondansetron (Zofran) use during pregnancy “should be considered in patients in whom other methods have failed.” Shaun D. Carstairs, MD, from the Division of Medical Toxicology, Department of Emergency Medicine, University of California, said Zofran is associated with a low risk for birth defects, and possibly a small increase in the incidence of cardiac malformations in newborns.
Although two of Laura’s children were born with heart murmurs, she realizes that it could have been a lot worse, had she continued to take Zofran.
More than 200 Zofran lawsuits have been filed in the United States, all claiming GlaxoSmithKline’s anti-nausea medication causes birth defects. The U.S. Judicial Panel on Multidistrict Litigation is consolidating all of them in a product liability litigation - MDL 2657.
“Only time will tell if my son will be okay, but I hope Zofran will be taken off the market sooner,” says Laura.
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