Zofran® Birth Injury Attorneys
Zofran should not be used by women for morning sickness. The drug has never been approved for this use, yet many doctors prescribe it off label to combat morning sickness. Evidence is now emerging that the drug can cause birth injuries.
Women Who Took Zofran® during the First Trimester
Lawsuits filed against Zofran's manufacturer claim that the pharmaceutical company promoted Zofran for purposes that were not approved by the U.S. Food and Drug Administration (FDA). The FDA approved Zofran to treat nausea and vomiting in chemotherapy, radiation therapy, and post-operation surgery in 1991.
The FDA never approved Zofran for use in pregnant women. Lawsuits against GlaskoSmithKline (GSK) allege that the big pharma company marketed Zofran for off-label use as an anti-nausea drug during pregnancy to treat morning sickness to women in their first three months of pregnancy.
Recent studies suggest a causal connection between newborns whose mother was prescribed Zofran during the first three months of the pregnancy and the following birth injuries:
- Cleft palate
- Cleft lip
- Heart abnormalities, including heart murmurs and atrial septal defects (hole in the heart).
- Other birth defects, including kidney abnormalities or missing kidneys
If you or someone you know was prescribed Zofran for morning sickness during pregnancy and had a baby with a birth defect, you may be entitled to compensation.
The Danger of Zofran for Pregnant Women
The purpose of the FDA approval process is to make sure a drug is safe for the specific people and conditions it was developed to treat.
While Zofran received approval to treat nausea and vomiting for chemotherapy, radiation therapy, and post-operation surgery, Zofran did not receive approval for use by pregnant women. The FDA did not review Zofran's safety when taken during pregnancy. Animal studies suggest that Zofran passes through the placenta to the baby, thus potentially increasing the likelihood of birth defects.
It should be noted that the manufacturer of Zofran, GlaxoSmithKline, pled guilty and paid about $3 billion dollars to resolve allegations of fraud, failure to report safety data, and the promotion of off-label uses for its drugs. In other words, GSK bought its peace with the Department of Justice for its improper practices related to Zofran. The settlement with the FDA did not resolve the civil claims of children injured by off-label use of Zofran.
Goldberg FinneganProtecting Your Rights!
If you or someone you know took Zofran during the first trimester of her pregnancy and had a baby with a birth defect, call our office for a free case consultation with an attorney.
Our dangerous drug attorneys have the experience you need on your side to get justice for you and your baby.
Don't wait. Speak to a Zofran attorney today to start your claim.
There are no upfront charges and your initial case review is also free of charge.