Zofran Linked to Hypospadias Birth Defect, Mother Furious

Deertrail, COAmanda recently filed a product liability complaint against GlaxoSmithKline (GSK), the maker of Zofran, claiming the drug she used during pregnancy caused her son to be born with a birth defect.

“My son was born with hypospadias, where the urethra forms abnormally and is not at the top of his penis,” says Amanda. “The urologist told me that it is a birth defect.” The urethra forms during weeks 8-14 of pregnancy: Amanda took Zofran to help treat morning sickness during her second trimester, which is from week 13 to the end of week 26.

The abnormal opening can form anywhere from just below the end of the penis to the scrotum, and there are different degrees of hypospadias; some can be minor and some more severe, according to the Centers for Disease Control and Prevention. Amanda’s son required surgery when he was two months old to correct the problem but he still suffers from the birth defect.

“I don’t know if I can put my son through another surgery,” says Amanda. “I first noticed that his penis wasn’t normal after his circumcision - he wasn’t urinating properly. Now 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. But I am getting a second opinion.”

When Amanda discovered last year that there was a link to Zofran and hypospadias, she was furious. “I cried so much, and the guilt is overwhelming. I am constantly dealing with this issue. You think that taking a drug is safe, especially for something ‘simple’ like morning sickness. Finding out the danger of this drug really is devastating, and very scary. And to top it off, I heard that the Zofran manufacturer was aware of Zofran birth defects yet didn’t recall it.”

In 2004, the medical journal An International Journal of Obstetrics and Gynaecology indicated a “possible” link between Zofran (ondansetron)] and hypospadias. The study noted that more studies are required and suggested that GSK lacked safety research on its drug. As well, the researchers said that “Despite the fact that it is not indicated, women are being prescribed this drug for the treatment of nausea and vomiting of pregnancy (NVP).”

“When my son pees, his penis points down at an angle. He has two holes, and urinates from one of them. He is a healthy boy except for this,” Amanda adds. “I didn’t take Zofran with my second child and he is fine. Thank god I didn’t have NVP with him, or maybe I was just able to handle the nausea better.

“I can’t believe there is a drug on the market that can harm innocent babies. I’d like to see that come off the shelf. I hope this message serves as a warning to pregnant women who are considering taking Zofran.” Add to Amanda’s warning, doctors who prescribe it.

The US Department of Justice in 2012 reached a $3 billion settlement with GSK after the government alleged the company promoted the off-label uses of several drugs, including Zofran.