Zofran Birth Defect Lawsuits

by Marilyn McGoldrick, Esq.

Published on June 17, 2015

They say that those that forget the past are doomed to repeat it.  More than 50 years ago, thousands of babies born to women that were prescribed Thalidomide for morning sickness developed severe birth defects.  The severity of the babies’ injuries was so great that many did not survive to term.  But did you know that similarly prescribed drugs – prescriptions that are being written as you read this –  are still given to pregnant women today? More than 50 years after the horrors of Thalidomide doctors are still prescribing Zofran (generic name: ondansetron) even though studies have shown that Zofran use is associated with the following serious birth defects and major congenital malformations:

Serious Birth Defects

  • Heart (cardiac) defects
  • Musculoskeletal abnormalities (like club foot)
  • Mouth deformities (like cleft palate and lip)
  • Craniosynostosis (abnormal shape of skull, may not have enough space for the brain, and cause eating, vision, and mental health issues)
  • Kidney malformations
  • Fetal growth restrictions

Off-label Prescribing of Zofran

Zofran is manufactured by pharmaceutical giant GlaxoSmithKline (GSK). In 2012 the U.S. government charged GSK with illegal marketing and to paying kickbacks to doctors to prescribe Zofran and other drugs for off-label uses. Zofran is only approved to treat nausea associated with chemotherapy, radiation, or surgery. Yet doctors – with GSK’s encouragement – prescribe it to pregnant women for nausea. GSK paid a $3 billion dollar file and plead guilty to the charges it had paid doctors to promote drugs like Zofran for off-label use.

Morning Sickness Treatment

Morning sickness can be a serious illness. Up to 80% of women are thought to experience nausea and vomiting during pregnancy, and 10-15% of those women are receive drugs to prevent morning sickness. The most extreme version of morning sickness, the relentless vomiting called hyperemesis gravidarum, can put both mother and unborn child at risk from dehydration and significant weight loss.

Safer Alternatives to Zofran

The FDA has approved one drug, Diclegis, to safely treat morning sickness. A combination of the antihistamine doxylamine succinate and vitamin B6 (pyridoxine hydrochloride), it is not associated with birth defects in the first trimester. GSK has never asked the FDA to approve Zofran for pregnancy-related nausea, and has never conducted any studies of its effectiveness or risks for pregnant women and their unborn children. The FDA has never approved Zofran for this purpose.

Study Finds Zofran Doubles Cardiac Malformation Risk

The largest study to date, of 900,000 Danish women, was published in 2013. It found that taking Zofran doubled a woman’s risk of bearing a child with a cardiac malformation birth defect, leading to a 30% increased risk of major congenital malformations – serious birth defects.

Experienced Birth Defect Lawyers

Since the 1980s, Thornton Law Firm lawyers have represented families of children injured by birth defects caused by pharmaceutical drugs such as Paxil, Prozac and other SSRIs, as well as birth defects caused by exposure to toxic substances including semiconductor chemicals, glycol ethers, pesticides, and solvents that are hazardous to reproduction.

Have You Taken Zofran?

One million pregnant women take Zofran for morning sickness each year. Most morning sickness occurs in the first trimester of pregnancy, when the fetus is the most vulnerable to developing birth defects. If you took Zofran and your child was born with a birth defect you may have the right to bring a lawsuit for damages. Call the experienced birth defect team at Thornton Law Firm at 888-341-1405 or tell us your story here to receive a free, confidential evaluation of your legal rights.  Like all legal claims, birth defect claims are subject to strictly enforced legal time limits. Do not delay seeking legal advice.

Thalidomide, Frances Oldham Kelsey, And The Pharmaceutical Industry

By Michael A. Lesser, Esq.

Posted on Sep 25, 2013

 

 

 

 

 

 

 

Dr. Frances Oldham Kelsey

Released in Germany in 1957 as an all-purpose sedative, but later widely used as a preventative treatment for “morning sickness,” Thalidomide caused an estimated 10,000 – 20,000 severe birth defects worldwide. The injuries associated with a mother’s ingesting Thalidomide while pregnant included birth without limbs, shortened limbs, deformed hearts and eyes, and blindness and deafness. It is estimated that 39-50% of babies born with Thalidomide-related birth defects died within a few months of birth. Thalidomide’s use increased after the drug became available over-the-counter in 1960. Before its use was banned, however, Thalidomide had been linked to birth defects in more than 39 countries.

The pharmaceutical company Richardson-Merrell (now Marion Merrell Dow) sought approval for sale of Thalidomide in the United States in June 1960. Because of a loophole in the approval process, however, Richardson-Merrell was able to distribute millions of doses of Thalidomide to more than a thousand doctors in the United States while the drug was being investigated. About 20,000 patients in the United States took Thalidomide as a result. Despite efforts to win quick approval from the Food and Drug Administration, Richardson-Merrell ran into an immovable force in the person of Frances Oldham Kelsey. Dr. Kelsey, who had only recently joined the FDA as a reviewing pharmacologist, resisted the requests for approval to market the drug and instead asked for more controlled studies related to Thalidomide’s risks. When studies showed that the drug’s use had lead to more than 10,000 severe birth defects worldwide, Richardson-Merrell pulled their application for approval. In 1962, Thalidomide was banned worldwide. Compared to other countries, only a relative handful of children in the United States were born with Thalidomide-related injuries. For her efforts, Frances Oldham Kelsey received the President’s Award for Distinguished Federal Civilian Service from President John F. Kennedy in 1962 and continued her work at the FDA.

As a result of the Thalidomide tragedy, many new regulatory reforms were enacted in order to better protect American consumers. Congress passed new rules related to testing and licensing of drugs.

Unfortunately, the potential for birth defects resulting from a mother’s use of pharmaceutical drugs is still present today. A new, peer-reviewed study has found that children born to mothers who took common prescription painkillers, like Vicodin, Oxycontin, or Percocet, at or near the time of conception were more than twice as likely to be born with neural tube defects such as spina bifida. The scientists found a strong association between mothers who took these prescription opioid painkillers and a significantly increased risk of having a child with one of these serious neural tube birth defects.

If you took an opioid painkiller around the time of conception and your child was born with a neural tube birth defect, please contact attorneys David Strouss or Marilyn McGoldrick at 888-341-1405 to discuss your legal rights with our experienced team of birth defect lawyers.

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