Birth defects caused by Zofran, lawsuit claims

Birth defects caused by Zofran, lawsuit claims

Patients going through chemotherapy and radiotherapy treatments in Nevada and across the country were relieved when GlaxoSmithKline released the drug Zofran in 1991. This powerful anti-nausea medication was approved by the FDA to alleviate severe nausea in treatment patients, as well as people suffering from the aftereffects of anesthesia. Shortly after the drug was released, however, physicians began rapidly prescribing the drug to pregnant women who were suffering from morning sickness in their first trimester, a fact known by Reno, Nevada product liability attorneys.

Incidentally, the drug was never tested on pregnant women and the effect the drug had on unborn babies was unknown. In fact, the American Journal of Obstetrics and Gynecology published a recent study indicating that taking Zofran increased the risk of severe congenital defects by 30 percent. Now, women around the nation are blaming the drug for causing severe birth defects of their babies.

The lawsuit

An Alabama woman has claimed that taking Zofran during the first trimester of her pregnancy caused her son to be born with several defects, including extra digits on his hands, a high narrow pallet, glaucoma and a distended kidney. Since birth, her son has had delayed reactions, suffered from seizures and doesn’t talk. According to, he was diagnosed with a chromosomal defect that cannot be linked to either the mother or father. The woman has filed a lawsuit against GlaxoSmithKline for negligence, breach of warranty, negligent failure to warn, strict liability and wantonness. She is one in over a dozen cases that have been filed against the company for negligence.

Off-label use

Although it is best for physicians to only prescribe drugs for indications that have been approved by the FDA, some physicians order drugs for conditions that have not been approved. Reno, Nevada product liability attorneys know that doctors are legally able to prescribe drugs for unapproved indications based on their sound judgement, medical expertise and knowledge. This is known as off-label use, and doctors who choose to use drugs for conditions other than those included on the drug’s labeling are required to maintain detailed records regarding its use.

Yet, according to a report published by The Legal Examiner, GlaxoSmithKline released a marketing campaign pushing Zofran as a safe and effective treatment for morning sickness, even though the FDA had not approved it for this use. Furthermore, evidence shows that the drug manufacturer had received more than 200 reports linking fetal defects to Zofran use and has not responded to or disclosed these reports.

Pregnant women who took Zofran for morning sickness, and subsequently had a baby that suffers from severe birth defects, may want to contact Reno Nevada product liability attorneys to explore their legal options.