A new study shows that Zofran, a popular morning sickness and nausea medication sometimes prescribed to pregnant women, increases the risk of severe birth defects. Because new information is being uncovered about the dangers concerning this medication, it is important to call a Phoenix Zofran birth defects lawyer if you were using this while pregnant. Knapp & Roberts can help you fight for your rights. They are experienced with birth defects cases and have helped clients all over Arizona.
What is Zofran?
The U.S. Food and Drug Administration (FDA) shows that Zofran “is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. It is in a class of medications called 5-HT3 receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.” Zofran is manufactured by GlaxoSmithKline and is also available in its generic form, ondansetron.
Although its original intention was to be used after surgery and for cancer patients, doctors continue to prescribe it “off-label” to treat nausea and vomiting during pregnancy in Arizona. The number of pregnant women prescribed Zofran has steadily increased for 50,000 prescriptions per month in 2008 to 110,000 at the end of 2013.
Study links Zofran with Birth Defects
In August 2013, a study of 900,000 Danish women found a “two-fold increased risk of cardiac malformation with ondansetron (Zofran), leading to an overall 30 percent increased risk of major congenital malformations.”
In December 2013, Australian researchers linked the use of Zofran in the first trimester with a 20 percent increased risk of birth defects. The study was published by BioMed Research International. The team found a possible sign of kidney defects and a 6-fold increased risk of malformations described as “obstructive defects of renal pelvis and ureter.” This can result in hydronephrosis, which can cause kidney failure. Conclusions from this study were on a small sample size and were imprecise.
A study published in the December 2014 issue of American Journal of Obstetrics and Gynecology shows the risks of pregnant women taking Zofran and notes conflicting student that cannot rule out dangers to a fetus.
What are the risks of taking Zofran?
There are a variety of drug side effects that have been linked back to Zofran, and some have been highlighted below.
- Heart defects including atrial septal defects (hole in the wall between the two upper chambers of the heart), ventricular septal defect (hole in the wall between the two lower chambers of the heart), and heart murmurs (abnormal sound heard in the heart using a stethoscope)
- Cleft palate: a birth defect within weeks 6-9 of pregnancy in which the roof of the baby’s mouth fails to develop. This typically causes an opening in the roof of the mouth and may connect to the nose, gums and upper lip. It can interfere with feeding and often requires reconstructive surgery.
- Cleft lip: a birth defect between weeks 4-7 of pregnancy in which the tissue of the upper lip does not join together properly. This results in an opening in the upper lip on one or both sides of the lip, or in the middle of the lip.
- Spina Bifida: a type of birth defect called a neural tube defect. It is a specific spinal cord injury that occurs when the bones of the spine (vertebrae) don’t form properly around part of the baby’s spinal cord.
- Kidney malformations
- Musculoskeletal abnormalities
- Fetal growth restriction
- Fetal death
Drug-maker GlaxoSmithKline (GSK) pays $3 billion for illegal marketing of Zofran, and more
On July 2, 2012, the Department of Justice announced a $3 billion settlement with GSK for “unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices.” It’s the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company. The settlement also resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.
History of Zofran
London-based pharmaceutical giant GlaxoSmithKline(GSK) created ondansetron (marketed under the brand name Zofran) in the mid-1980s. It was granted a U.S. patent in September 1987, received a use patient in June 1988, and was approved by the FDA in January 1991.
The FDA first approved Zofran for chemotherapy, radiation therapy, and post-operative related nausea and vomiting only. GSK’s patent expired in 2006. That’s when the FDA approved the first generic versions of ondansetron to Teva Pharmaceuticals USA and SICOR Pharmaceuticals. GSK continued to market and sell Zofran even as generics became available.
By the year of GSK’s final patent in 2006, Zofran became its 20th highest selling drug in the U.S. with sales of $1.3 billion in the first 9 months. Some of these sales were the result of prescriptions to pregnant women for morning sickness, even though it was not approved by the FDA.
Between 1983 and 2013, no drug was approved to treat morning sickness for pregnant women. In 1983, the drug Bendectin (pyridoxine/doxylamine) had been removed from the market, but the pyridoxine/doxylamine combination continued to sell on the market under different brand names for the next 30 years.
Because no drug was available, doctors began prescribing drugs for non-approved uses, including Zofran, for pregnancy-related nausea and vomiting.
After years of studies, the FDA approved the return of the combination of pyridoxine and doxylamine under a new name: Diclegis. Despite the approval of Diclegis for morning sickness, an estimated one million women were still prescribed Zofran or a generic equivalent of ondansetron last year.
Countless pregnant women had and continue to have babies born with birth defects because of these drugs, resulting in pain and suffering, medical expenses, loss of income, emotional distress, and more.
About GlaxoSmithKline (GSK)
GSK is the 6th largest pharmaceutical company in the world (measured by revenue). Based in London, they manufacture drugs and vaccines for major disease areas such as asthma, cancer, infections, diabetes, digestive and mental health conditions. Their biggest selling brands were Advair, Avodart, Flovent, Augmentin, Lovaza, and Lamictal in 2013. GSK manufactures, markets, and/or distributes more than 183 drugs in the U.S. As of May 2, 2014, it had a market capitalization of £79 billion, the 4th largest company listed on the London Stock Exchange.
Zofran lawsuits filed
A mother from Massachusetts and a mother from Minnesota have both filed lawsuits against GSK in mid-February, raising nearly identical allegations that due to Zofran use during pregnancy, their children were born with severe birth defects.
One complaint filed in the U.S. District Court for the Eastern District of Philadelphia on February 12 by Cheri Flynn indicates that her two children, born in 2004 and 2006, suffered congenital heart defects after exposure to Zofran during her pregnancy. Her older daughter’s condition at birth and in her early years of life prevented her from thriving physically and developmentally. Because of this, her daughter was forced to undergo surgery in 2011 to repair the hole in her heart and has undergone. When her younger daughter was born, she was unable to breathe adequately and required 24-hour monitoring with an electronic alarm that would alert her parents and caregivers that her oxygen levels were dangerously low. Her condition also stifled her growth and development, causing her growth metrics to fall short of the fifth percentile compared with other children her age.
Another complaint filed by Tomesha LeClair in the U.S. District Court for the District of Massachusetts on February 16, indicates that her daughter suffered heart defects and several other congenital malformations due to the use of Zofran during her first trimester of pregnancy. After birth, echocardiograms showed that her daughter suffered from an atrial septal defect, right ventricular hypertension and aortic arch hypoplasia, as well as facial dysmorphia, low set ears, hearing loss, sensitivity to light, ingueno hernia, and webbed toes. In 12 years, her daughter has had to undergo ten surgeries to try and correct her numerous congenital abnormalities. Furthermore, the lawsuit states that these birth defects impair her development and enjoyment of a normal life at home and at school due to substantial developmental delays.
Both lawsuits indicate that GSK has known the potential link between Zofran and birth defects for quite some time. The complaints also say that GSK performed studies in the mid-1980s, which showed that Zofran crossed the placenta in rats and rabbits during pregnancy. The lawsuit also claims that despite their studies showing toxicity, premature births, intrauterine fetal deaths and incomplete bone growth, the company declared the tests showed no harm to fetuses.
In 1992, GSK started receiving mounting evidence of reports of birth defects associated with Zofran. By 2000, GSK had 32 reports of women who used the drug and later gave birth to women with congenital heart disease, dysmorphism, stillbirth, kidney defects, bone and skeletal problems and other birth defects. To date, GSK has received more than 200 reports.
Do you have a case?
If you or someone you know took Zofran while pregnant and their child suffered a birth defect, contact a Phoenix zofran birth defects lawyer at Knapp & Roberts immediately for a free initial consultation. They work with clients who are faced with the devastating effects of personal injuries all over Arizona. Call 480-991-7677 or fill out our online form here.