Metroclopramide, another anti-nausea drug sometimes used for morning sickness, was not associated with birth defects.
Interestingly, six months before this study was published, the New England Journal of Medicine published another study based on 600,000 births in Denmark that found no evidence of fetal harm. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments.
When used during pregnancy, the anti-nausea medication Zofran has been associated with birth defects, including heart defects and cleft palate. This can cause a loss of consciousness, low blood pressure, and sudden death.
FDA Warnings for Zofran Side Effects
The FDA first warned about Zofran side effects in September 2011. The taking zofran for morning sickness recall is unlikely to affect many patients because the dose makes up only a small percentage of the drug’s market.
Do I have a Zofran Lawsuit?
The Schmidt Firm, PLLC is currently accepting Zofran induced injury cases in all 50 states. It is also prescribed in lower doses to patients after surgery.
Zofran and Pregnancy
Zofran is commonly used “off-label” to prevent nausea and vomiting associated with morning sickness during the first trimester of pregnancy. Although animal studies found no evidence of pregnancy side effects, a growing number of population-based studies have found evidence linking Zofran and birth defects.
In August 2013, Zofran was linked to a 30% increased risk of birth defects and a doubled risk of heart defects in the study, “Ondansetron use in early pregnancy and the risk of congenital malformations.”.
Conclusions were based on data from nearly 900,000 pregnancies in Denmark between 1997 and 2010. The study was completed in June 2012, and found http://cancer.emedtv.com/zofran/zofran-side-effects.html that a single 32-mg dose of Zofran was associated with QT interval prolongation.
Serotonin Syndrome
March 2013 — The FDA has identified a “potential safety issue” about the risk of serotonin syndrome from Zofran and other drugs in the 5-HT3 class, which work by influencing serotonin levels. However, the study was too small to estimate the risk of individual birth defects with any precision.
Zofran Pregnancy Side Effects
Our attorneys are investigating cases involving:
Other pregnancy side effects of Zofran may include:
Fetal growth restriction (poor growth in the womb)
Jaundice
Kidney defects
Life-threatening complications for mother (serotonin syndrome, irregular heart rhythm, Torsade de Pointes, etc.)
Fetal or maternal death
Zofran Side Effects
Zofran is associated with life-threatening cardiac side effects. If you or somebody you know had a baby with a birth defect after using Zofran during pregnancy, you should contact our lawyers immediately for a free case consultation. The 32-mg dose of Zofran increases the QT interval by an average of 20 milliseconds, and the 8-mg dose is associated with a 6 millisecond change.
In severe cases, QT interval prolongation longer than 600 milliseconds can lead to Torsades de Pointes. Birth defects occurred in nearly 5% of the 1,250 women who used Zofran in the first trimester, compared to 3.5% of women who did not. It was approved in 1991 by the U.S. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
What is Zofran?
Zofran (ondansetron) is an anti-nausea drug created by GlaxoSmithKline (GSK). The FDA has also issued safety warnings about deadly heart problems, including a deadly abnormal heart rhythm disorder called Torsade de Pointes.
What You Can Do How We Can Help
The Schmidt Firm, PLLC is currently accepting Zofran induced injury cases in all 50 states. The agency updated the label on Zofran to warn that it could increase the risk of “developing prolongation of the QT interval of the electrocardiogram, which can lead to an abnormal and potentially fatal heart rhythm, including Torsades de Pointes.”
After this warning, the FDA required the manufacturer to study what dose of Zofran was associated with cardiac risks. The risk of serotonin syndrome may be compounded in individuals who also use SSRI antidepressants, which also influence serotonin
Serotonin syndrome side effects:
Agitation or restlessness
Confusion
Rapid heartbeat and high blood pressure
Loss of muscle coordination, twitching or rigid muscles
Heavy sweating
Diarrhea
High fever
Seizures
Irregular heartbeat
Loss of consciousness
Zofran Recall
More than a year after the FDA first warned about Zofran side effects, the agency recalled 32-mg intravenous Zofran in December 2012. Results were published in Reproductive Toxicology.
Another recent study, published by BioMed Research International in December 2013 by Australian researchers, linked the use of Zofran in the first trimester with a non-significant 20% increased risk of birth defects and higher rates of kidney defects. Food and Drug Administration (FDA), and is now available as a generic medication called Onsandestron. Zofran works by inhibiting 5-HT3 serotonin receptors.
Zofran is primarily prescribed to treat nausea and vomiting in patients undergoing chemotherapy. If you or somebody you know has been injured by Zofran, you should contact our lawyers immediately for a free case consultation. This can cause a disorder called QT interval prolongation, in which the electrical charge in the heart takes longer than 440 milliseconds to recover between each beat. Unfortunately, this is a critical time in fetal development when many birth defects can occur.
Zofran is not approved by the FDA for morning sickness and it is “Pregnancy Class B,” which means placebo-controlled studies have only been conducted in animals. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.
. The drug can interfere with electrical activity in the heart, which may cause a fatal irregular heart rhythm disorder. However, 50% of the women took Zofran after the first trimester, when their baby was no longer at risk of many birth defects.
More recently, an investigative report by the Toronto Star found nearly two dozen case reports linking Zofran with heart defects, kidney problems, musculoskeletal abnormalities, and other birth defects.
In December 2014, Swedish researchers looked at data on 1,400 Zofran-exposed pregnancies from 1998-2012 and found that Zofran doubled the risk of septal heart defects. The heart may flutter ineffectively and suddenly stop beating. Cardiovascular side effects of Zofran may include:
Chest pain, tightness, or discomfort
Irregular heart rhythm
Abnormally fast, slow, or weak pulse
QT interval prolongation
Torsades de Pointes
Ventricular arrhythmia
Zofran is also associated with the following serious side effects:
Muscle weakness
Fatigue
Dizziness
Headaches
Allergic reaction
Swelling of the face, lips, tongue
Fever
Diarrhea
Constipation
And more
Cardiovascular Zofran Side Effects
Zofran can interfere with electrical activity in the heart
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