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Zofran Lawsuit

Zofran is a drug conventionally used to treat nausea and vomiting induced by chemotherapy treatments. While the drug is very effective for this purpose, it was recently revealed that it was being marketed off brand as a viable treatment for severe morning sickness in pregnant women. The drug has since been potentially linked to birth defects in the children of women who used the drug during pregnancy. The makers of the drug, GlaxoSmithKline, are being sued for damages by women who feel their children’s birth defects are the result of adverse side effects of the drug which they were not warned of.

Birth defects potentially resulting from the use of Zofran while pregnant include: congenital heart defects, cleft lip, cub foot, and cleft palate. Many allege that GlaxoSmithKline knew as early as 1992 that Zofran could potentially cause harm to the unborn children of pregnant users. The company continued to market the drug to pregnant women despite the knowledge of these risks, potentially endangering the children of these women without informing them of the risks associated with this treatment.

The U.S. Food and Drug Administration approved Zofran for the use of treatment for chemotherapy patients experiencing nausea and vomiting side effects. However, according to the website of Zofran attorneys at Williams Kherkher, “many argue that Zofran was never intended or approved by the FDA to be used by pregnant women for the purpose of mitigating the effects of morning sickness.” If this is true, GlaxoSmithKline had a duty to warn mothers of these risks, and a moral obligation to not market this drug for purposes they knew to be harmful. As a result, some children may be born with Zofran-related birth defects.

Zofran and its Possible Side Effects

Chemotherapy and radiation therapy can make the long road to recovery from cancer a truly miserable experience. When Zofran was created to help with the nausea and vomiting side effects of cancer drug treatments, it helped thousands of people. The drugs works by blocking serotonin the substance in the body that causes vomiting.

Common side effects of using the drug include headaches, lightheadedness, dizziness, or constipation. However, there are reports that women who took Zofran while pregnant are having children with serious birth defects. There’s a correlation between the drug and birth injuries that include cleft lips, cleft palates, and congenital heart defects. Zofran was previously prescribed to pregnant women experiencing morning sickness.

Ondansetron, the active ingredient in Zofran, was assigned a pregnancy category B by the U.S. Food and Drug Administration. This means that the use of Zofran should only be considered when the benefits to the pregnant mother outweigh the risk of birth defect to the infant. Animal studies of the drug did not reveal any indication that the Zofran causes birth defects. Currently there is no controlled data about human pregnancy and birth after the drug was taken, and therefore no substantial data as to side effects related taking Zofran while pregnant.

Zofran works by curbing the natural substance serotonin in the body. Drugs that are serotonergic are known to cause birth defects when taken by pregnant women during the most important stages of fetal development. The drugs Paxil and Zoloft are examples of this.

If your child was born with birth defects that you believe were caused by the use of Zofran while pregnant, consult a Zofran lawyer in your area to discuss legal options. The physical, emotional, and financial damages you and your child have suffered deserve compensation.