This is just crazy! With my last pregnancy I had horrible sickness and many many times I almost went and picked up the Zofran prescription at the pharmacy that my Dr. had sent there for me, but I never did. I had read an article about how it *may* have been linked to birth defects and now it most certainly has.
Please share this to prevent pregnant moms from taking this and also to get the word out there to moms of babies born with defects who took ZOFRAN during pregnancy.
Originally Published on April 27, 2015 by Laurie Villanueva on www.zofranlawsuit2015.com
In about two months, the U.S. Food & Drug Administration (FDA) will enact new pregnancy labeling rules for prescription drugs. With Zofran birth defects lawsuits beginning to mount in courts around the country, the agency’s plan seems especially timely.
According to the FDA, expectant mothers take an average of three to five prescription drugs during pregnancy. The new labeling format, which goes into effect on June 30, 2015, reorganizes information and is structured in a way that the agency hopes will better inform health care professionals’ prescribing decisions. Once the rule is enacted, newly approved drug and biological product applications will be required to use the new format immediately. The rule will be phased in gradually for previously-approved products, such as Zofran.
The FDA’s new regulations will replace product letter categories – A, B, C, D and X – currently used to classify the risks of using prescription drugs during pregnancy with three detailed subsections that describe risks within the real-world context of caring for pregnant women who may need medication. Each subsection – “Pregnancy,” “Lactation” and “Females and Males of Reproductive Potential” – includes a summary of the risks of using a drug during pregnancy and breastfeeding, a discussion of the data supporting the summary and relevant information to help doctors make appropriate prescribing and counseling decisions for their patients.
Zofran and Pregnancy
Once the new rules are phased in to include Zofran and generic versions of the anti-nausea drug, the modified label will hopefully give expectant mothers and their healthcare providers better guidance on its use in pregnancy. Currently, Zofran is not approved to treat pregnancy-related nausea and vomiting, but it has been routinely prescribed for that purpose. The current label now classifies the drug as Pregnancy Category B, indicating that while animal reproduction studies have failed to demonstrate a risk to the fetus, there are no adequate and well-controlled studies in pregnant women.
In recently months, a growing number of Zofran birth defects lawsuits have been filed against GlaxoSmithKline which accuse the company of marketing the medication as a safe and effective treatment for morning sickness, even though it had never conducted any human trials to investigate its effects on a developing pregnancy. The complaints have been filed on behalf of children who allegedly developed cleft lip and plate, heart abnormalities and other serious birth defects due to their mothers’ use of Zofran during the first trimester of pregnancy.
If you believe your child suffered a congenital defect due to Zofran, your family may be entitled to compensation from Glaxo. To learn more about filing a Zofran lawsuit, please call (888) 881-3077 to arrange for a free legal consult with the nationwide law firm of Bernstein Liebhard LLP.