March 4, 2016 — San Diego, CA Zofran is manufactured by GlaxoSmithKline and has been on the market for more than 20 years. It was originally approved in the United States by the FDA in 1992, and it is mainly used by cancer victims to treat nausea caused from chemotherapy.
Zofran works by reducing the effects of a substance in the body that is known as serotonin. Serotonin is known to cause nausea and ultimately vomiting and since many women get morning sickness during pregnancy, Zofran was prescribed. It basically interrupts the messages sent from the brain to the rest of the body that it should feel nauseous and get ready to vomit.
Zofran was marketed to pregnant women for the last few years, which was seen a vast new market for this drug, even though it was never approved by the FDA for use in pregnant women. This is a perfect example of “Profits over People”. However one lawsuit issued by the Department of Justice slapped GlaxoSmithKline with a complaint of unlawful promotion and failure to report safety data of its blockbuster drug Zofran. GlaxoSmithKline agreed to settle the issue for $3 billion dollars.
Lack of proper Zofran testing in pregnant women creates a major concern for women, and some medical studies are showing a very real risk of birth defects in newborns who mothers took Zofran in any trimester.
One such study was done by the Fertility Centers of New England, with a clear warning that pregnant women not take Zofran. Source: http://www.fertilitycenter.com/fertility_cares_blog/fda-warns-against-zofran-use-in-pregnancy/
“Based on recent studies regarding the association between Zofran use in early pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has cautioned against its use in pregnancy. There are also potential maternal risks associated with taking Zofran especially in pregnant women with electrolyte imbalance due to severe nausea and vomiting.”
Stories of babies born with debilitating side effects began rolling into our office on a daily basis.
Back in March last year a young woman filed a Zofran lawsuit claim with us, read her story here: https://www.nationalinjuryhelp.com/dangerous-drugs/mothers-story-zofran-birth-defects/
Needless to say that these stories touch us very much and we take pride in helping these families that have been devastated by Zofran. We’ll continue the good fight to hold these pharmaceutical companies accountable for the pain and suffering they’ve caused.
If you’ve had a baby born with a birth defect and you were prescribed Zofran, contact our office today for a free case review. 1-800-214-1010 or use our online evaluation form https://www.nationalinjuryhelp.com/zofran-claims-compensation-evaluation/
Article: Zofran and Pregnancy – The Risks are Dangerous and Real, published on March 4, 2016