A new lawsuit filed against GlaxoSmithKline (GSK) alleges that prenatal exposure to the anti nausea medicine Zofran causes serious birth defects.

Plaintiff Renee A., a resident of Alabama, began taking the anti nausea medicine Zofran back in 2006 during the first trimester of her pregnancy.

She used the medication throughout her first and second trimester in order to relieve pregnancy-related nausea also known as morning sickness.

The lawsuit alleges that Renee’s physician would not have prescribed the anti nausea medicine to her and she would not have taken the drug if they had known about the true risks associated with taking Zofran while pregnant.

Renee’s baby was born in April of 2007 with various birth defects including a missing kidney According to Renee, there is no family history of birth defects reflecting those of her baby.

She alleges that GSK violated consumer protection laws by misrepresenting to the public and medical professionals that Zofran was safe for pregnant women.

Additionally, the Zofran lawsuit states that the pharmaceutical company fraudulently concealed facts and information that would have allowed Renee to make an educated decision about using the anti nausea medicine.

Claims against GSK include negligence, negligent misrepresentation, fraudulent misrepresentation, breach of warranty, and products liability.

Renee is seeking both compensatory and punitive damages for the injuries her and her minor child suffered while she was pregnant and taking Zofran.

What is Zofran?

Zofran, generically known as ondansetron, is an anti nausea medicine prescribed to prevent nausea and vomiting in cancer patients undergoing cancer treatment and radiation therapy and to patients who experience nausea and vomiting after surgery.

The medication works by blocking chemicals in the body that often trigger nausea and vomiting.

Zofran Anti Nausea Medicine Risks

Renee’s lawsuit alleges that GSK knew as early as 1992 that Zofran exhibited evidence of human fetal risk when ingested during pregnancy but failed to update the medication label to disclose those risks.

Zofran is required by federal law to be labeled as a pregnancy category D medication or alternatively a category X medication.

A category D warning states that the potential benefits of a medication may be acceptable despite its risks if the drug is necessary for a life threatening situation or serious disease.

Category X medications are those that the risk of using the medication while pregnant clearly outweighs any potential benefit.

Recently the FDA declared that pharmaceutical companies are required to summarize the risks of using a medication while pregnant and can no longer merely use these category designations.

Women and children who have been adversely affected by the side effects of Zofran may be able to file a lawsuit against GSK.  Other Zofran side effects include cleft lip, heart defects, kidney defects, musculoskeletal defects, poor fetal growth, and fetal death.

The Zofran Lawsuit is Case No. 1:16-cv-10775 in the United States District Court in the District of Massachusetts.