Study Published in 2004 Linked Zofran and Hypospadia Defect

Study Published in 2004 Linked Zofran and Hypospadia DefectApril 7, 2015 — A study published over a decade ago found evidence linking the use of Zofran in pregnancy with hypospadias, but no further research has been done by GlaxoSmithKline (GSK).

The medical journal BJOG: an International Journal of Obstetrics and Gynaecology published the study, “The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study” in September 2004.

Researchers looked at data on 176 women who used Zofran to treat nausea and vomiting in pregnancy (NVP). There were six babies born with birth defects (3.6%), including three babies with hypospadias that needed to be treated with surgery.

According to the researchers:

“This is an increase in the rate of hypospadias in the general population (though not statistically significant), where this abnormality occurs in approximately 1 in every 300 males.”

However, none of the hypospadias were severe — two were mild and one was moderate. Furthermore, the sample size was too small to make any conclusions about whether Zofran increased the rate of hypospadia. No risk was seen in animal studies.

Even so, the researchers cautioned: “[Zofran] was never intended or labeled as such to be a treatment for NVP. Consequently, there is a paucity of data in the literature on the safety of [Zofran].”

Hypospadia is a birth defect in which the opening of the urethra is located somewhere other than the tip of the penis. It can cause a number of complications, depending on the location of the opening. If not corrected, the boy may need to urinate while sitting down. Untreated hypospadia can also cause sexual dysfunction.

Need a Texas Zofran Lawyer?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Zofran lawyers for a free lawsuit review.

Free Case Review

Verified 100% Secure Site

To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 879-3040.

*
*
*