Zofran Kidney Defect

Zofran Kidney Defect
A number of reports have linked to Zofran to kidney defects in babies who were exposed to the anti-nausea drug during the first trimester of pregnancy. At least one study has suggested that pre-natal exposure to Zofran may increase the risk of certain kidney birth defects by as much as six fold.

Zofran Birth Defects Investigation

The attorneys at Bernstein Liebhard, a nationwide law firm that represents the victims of serious drug side effects, is investigating reports of Zofran-related kidney defects and other birth defects that may be associated with the use of this medication by pregnant woman. If you were prescribed Zofran during the first trimester of pregnancy and believe your child was harmed as a result, please contact our office at (888) 994-5118.

Zofran Kidney Defects Reports and Studies

Recently, several studies and reports have linked first-trimester exposure to Zofran to the development of kidney birth defects:

  • 2013: A study published in Biomedical Research International suggested women who used Zofran in the first trimester of pregnancy were 20% more likely to have a child with serious birth defects. The same study linked Zofran to a 6-fold increase risk of f kidney defects, described as “obstructive defects of renal pelvis and ureter.” However, the author of the study acknowledged that their findings were imprecise and based on a small study.
  • 2014:The Toronto Star reported that at least 20 Canadian women treated with ondansetron – the active ingredient in Zofran — for vomiting in pregnancy experienced serious complications, including multiple cases of newborns with heart defects and kidney defects.

Common Kidney Birth Defects

Defects of the kidneys and urinary tract develop in roughly 1 in 500 births. In fact, birth defects occur more frequently in the kidney and urinary system than in any other system of the body. Some of the most common include:

  • Ectopia (kidneys form in the wrong place)
  • Malrotation (kidneys in the wrong position)
  • Horseshoe kidney (the two kidneys are joined together)
  • Kidney agenesis (missing kidney)
  • Potter’s Syndrome (both kidneys are missing, causing death)
  • Polycystic Kidney Disease (cysts or fluid-filled sacs form inside the kidney)
  • Medullary sponge kidney/MSK (urine-containing tubules of the kidneys are dilated)
  • Cystinosis (metabolic kidney disease)

Zofran in Pregnancy

Zofran is currently not approved to treat pregnancy-related nausea and vomiting, and its effects on a developing fetus have not been well-studied. However, a recent analysis indicated that as many a 1 million women annually have been prescribed the drug in the U.S. to treat pregnancy-related nausea and vomiting.

While doctors are permitted to prescribe FDA-approved medications in any manner they see fit, drug companies may not promote the off-label use of their products. In 2012, GlaxoSmithKline agreed to pay $3 billion to settle federal criminal and civil charges involving the marketing of several of its medications. Among other things, the U.S. Department of Justice had accused the company of promoting Zofran as an off-label treatment for morning sickness.

Zofran Birth Defects Litigation

A growing number of Zofran lawsuits claim that that the company has received numerous reports of birth defects potentially associated with Zofran, but withheld this information from the public and medical community. Read More

October 2015: Dozens of Zofran lawsuits have been centralized in the U.S. District Court, District of Massachusetts, for the purposes of coordinated pretrial proceeding. By November 2015, more than 100 such cases had been filed in the proceeding on behalf of children who were allegedly born with Zofran-related birth defects due to their mothers’ use of the drug in the first trimester of pregnancy. Read More

Discuss Your Case with a Zofran Lawyer Today

The Zofran lawyers at Bernstein Liebhard LLP are now offering free, no-obligation legal reviews to any family whose child suffered kidney birth defects or other complications that may be associated with pre-natal Zofran exposure. To arrange for your confidential case consultation, please call (888) 994-5118 today.

  1. Biomedical Research International (2013) “Off-Label Use of Ondansetron in Pregnancy in Western Australia” http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3874333/
  2. AJOG (2014) “Treating morning sickness in the United States—changes in prescribing are needed” http://www.ajog.org/article/S0002-9378%2814%2900853-9/abstract
  3. The Toronto Star (2014) “Birth defects blamed on unapproved morning sickness treatment” http://www.thestar.com/news/gta/2014/06/25/birth_defects_blamed_on_unapproved_morning_sickness_treatment.html
  4. Merck Manual (2015) “Urinary Tract Defects” http://www.merckmanuals.com/home/children-s-health-issues/birth-defects/urinary-tract-defects
Last Modified: February 24, 2016

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