Lawsuits are being filed in Tennessee, Kentucky, and other states as patients discover that Zofran® has been linked to an increased risk of birth defects.
These claims allege that Zofran®’s manufacturers had knowledge of the side effects, but did not provide adequate warnings to the FDA, consumers, or medical providers. Claimants further feel that this medication should not have been marketed or sold without additional testing on pregnant women.
Now is the time to contact the personal injury team at Hughes & Coleman. We are ready to work with you and help you recover the compensation you may be entitled to.
OFF-LABEL USE AND SIDE EFFECTS
Zofran®, commonly used for cancer patients, helps to prevent nausea and vomiting that may result from chemotherapy and radiation.
When the medication is used for its labeled purposes, it is reported to have minor side effects including constipation, headaches, and mild dizziness.
Unfortunately, medical professionals have used Zofran® for off-label purposes and have prescribed the medication to pregnant women experiencing severe morning sickness and nausea. Plaintiffs claim that this is a result of insufficient warnings labels.
Zofran® has been shown to quickly and rapidly pass through the placenta to the baby. The medication is then delivered in high doses from the mother to the baby and can remain present in the fetus longer than in the mother.
As a result, Zofran® has been linked to serious birth defects, especially when taken within the first trimester of pregnancy. Plaintiffs claim that medical professionals and consumers were not provided adequate warnings about the association between this medication and the potential birth defects.
Serious birth defects may include:
- Cleft palate
- Skull deformations
- Mental problems
- Physical deformation
- Club foot or webbed toes
- Hearing loss
- Heart defects
- Abnormal blood pressure
- Vision problems
Zofran® is manufactured by GlaxoSmithKline (GSK) and comes in an injectable dose or pill form. The injectable dose first gained FDA approval in 1991 for use as an anti-nausea and vomiting medication for chemotherapy patients. In 1995, the pill form of Zofran® was approved by the FDA and introduced to the market.
It wasn’t until 2014 that studies revealed side effects of this medication. In these studies, it was found that use of this medication while pregnant can lead to an increased risk of heart deformations and defects. Earlier studies conducted in 2011 showed that birth defects were likely when pregnant women took Zofran®.
Patients claim that GSK knew about these birth defects or should have known about them citing studies as far back as 1980. These studies show that GSK conducted clinical trials with animals which resulted in premature births, toxicity, incomplete bone growth, and fetal death. In addition, some of the animals that were part of the study were born with retardation and heart defects.
In 2012 the FDA issued a recall for Zofran®, specifically the IV 32 milligram dose, due to cardiac risks associated with it. The oral medication was never recalled.
Lawsuits filed by users of the drug claim that GSK had prior knowledge of the serious side effects related to the use of Zofran® in pregnant women, but failed to properly inform the government, medical professionals, and consumers.
Had patients felt they were properly informed about these side effects, it is likely that many pregnant women would not have chosen to use the drug to treat their prenatal nausea.
Zofran® may cause both minor and more serious side effects.
Minor and common side effects include:
- Drowsiness
- Constipation
- Weakness
- Headache
- Diarrhea
Severe side effects include:
- Seizures
- Shortness of breath or difficulty breathing
- Rash or hives
- Chest pains
- Blurry vision
- Coma or short-term loss of consciousness
HUGHES & COLEMAN IS READY TO HELP YOU
The team at Hughes & Coleman are ready to provide you a free consultation. Whether you or a loved one was injured by Zofran®, you deserve answers and you may be entitled to compensation for those injuries.
If you would like to find out if you qualify for compensation for emotional trauma, medical bills or birth injuries, contact our team today. We are available 24 hours a day, 7 days a week. Call Hughes & Coleman now for your FREE case evaluation.
Cases likely to be referred.
Do not stop taking a prescribed medication without first consulting your doctor. Discontinuing a prescribed medication without your doctor’s advice can result in injury or death.