An Arkansas mother has taken legal action against the anti-nausea drug Zofran for allegedly causing her son to develop numerous birth defects.

An Arkansas mother named Jody Huffmaster has joined the ranks of more than 60 parents fighting against Zofran.

During her pregnancy, Huffmaster took Zofran to treat symptoms of morning sickness. The anti-nausea drug, originally approved for cancer patients, allegedly caused Huffmaster’s son to develop numerous congenital birth defects.

Huffmaster has pursued legal assistance to gain “compensatory damages” and equitable relief to ensure that future mothers-to-be are fully informed about the potential risks of Zofran.

Mother Claims Zofran Exposure Caused Her Son’s Defects

Huffmaster’s son was born with clubfoot, a condition in which the foot is twisted out of shape or position.
Image: National Library of Medicine

Huffmaster’s son, referred to in court documents as B.H., has “numerous” birth injuries. In her claim, she identifies Zofran as the culprit.

B.H. was born with a cleft palate, which is a condition that causes an opening or split in the roof of her son’s mouth and lip. Children with cleft palates may develop speech disorders, stuttering, an impaired voice, feeding difficulties, hearing loss, mouth breathing, nasal congestion or snoring.

In addition, B.H. suffers from bilateral clubfoot. This condition affects the lower half of the body, creating a twist in the shape or positioning of the foot. Bilateral clubfoot may cause an abnormality while walking, calluses, knock knees or shortened legs.

Although B.H. was lucky enough to be born with a healthy heart, the majority of birth defects associated with prenatal exposure to Zofran are cardiovascular. However, B.H. was also diagnosed with respiratory distress syndrome. This means his lungs weren’t fully developed when he was born, causing difficulty breathing and potential organ damage.

A Family Dealing With Mounting Medical Costs

Families with children who require multiple medical procedures often need financial assistance.
Image: Dynamic Chiropractic

At just 8 years old, Huffmaster’s son has undergone two serious surgeries. Although court documents don’t specify if the procedures repaired his clubfoot, it’s likely that his cleft palate was treated.

Throughout his life, B.H.’s family has had to shoulder his medical expenses. Because the cost of multiple medical procedures is high even for families with excellent health insurance, it can be extremely difficult to come up with enough funding to cover birth defect surgeries.

On September 14, 2015, Huffmaster filed a lawsuit against the makers of Zofran. Her family is requesting damage awards that will assist with paying B.H.’s mounting medical bills.

She is suing for her family’s “severe and permanent pain and suffering, mental anguish, medical expenses and other economic and noneconomic damages, and will require more constant and continuous medical monitoring and treatment than had they not been exposed to Zofran,” according to court files.

Additionally, Huffmaster hopes the lawsuit will help to warn future mothers about the possible risks of Zofran. 

If you took Zofran while pregnant and if your child was born with birth defects, you might be entitled to compensation.

Complete a free, no-obligation case evaluation now to see if you qualify.

The post Arkansas Family Files Against Zofran For Cleft Palate And Clubfoot Defects appeared first on Citizens Report.

Zofran, also known by its generic form ondansetron, is meant to be used for cancer-related nausea.

Zofran has been approved for the most severe cases of nausea, but GlaxoSmithKline has promoted it as a treatment for morning sickness to increase its popularity and profits.

The misuse has reportedly caused birth defects in newborns, which led many mothers to file lawsuits against the drug manufacturer.

Multiple studies question the safety of Zofran when used by pregnant women. Cleft lips, cleft palates, club feet, craniosynostosis and congenital heart and lung problems are a few of the birth defects that may have stemmed from the use of Zofran while pregnant.

What is Zofran?

Zofran comes in many forms, but the disintegrating oral tablet is the most popular.
Via: Top Class Actions

Manufactured by GlaxoSmithKline, Zofran was approved by the FDA in 1991 to treat cancer patients suffering from nausea. The drug is an 5-HT3 receptor antagonist that acts on serotonin receptors to block negative symptoms. It’s also known by its generic form ondansetron.

Zofran is prescribed for nausea and vomiting caused by cancer medication or surgery, such as chemotherapy or radiation. It has not been designated for any other causes of nausea, including morning sickness. However, the manufacturer GlaxoSmithKline unlawfully encouraged doctors to prescribe it for other uses.

Side Effects of Zofran

A few of the side effects of zofran are blurred vision, tiredness and impaired thinking.
Via: Ketogenic Diet Resource

Side effects of zofran include, but are not limited to:

• blurred vision or temporary vision loss
• impaired thinking
• irregular heart rate
• jaundice
• difficulty breathing
• anxiety or agitation
• shivering
• unusual urination patterns
• diarrhea or constipation
• drowsiness or tiredness

The drug is known for bad reactions with certain medications such as apomorphine (Apokyn). In addition, it should not be taken if the patient has a history of phenylketonuria, liver disease or the heart condition long QT syndrome.

The drug’s active ingredient is ondansetron, which many patients may be allergic to. In addition, researchers believe that Zofran may harm a nursing baby through a woman’s breast milk. It should not be used when breast-feeding.

Research Shows Pregnancy Risk

Many women have taken zofran throughout their pregnancy, which has caused birth defects such as Cleft lips, cleft palates, club feet, craniosynostosis and congenital heart and lung problems.
Via: Top Class Actions

Doctors have been prescribing Zofran to treat morning sickness since 1992, only a year after it was approved for use in cancer patients. The pharmaceutical manufacturer GlaxoSmithKline engaged in unlawful off-label promotion of the drug despite the fact that conflicting scientific studies question the safety of Zofran for other uses.

In December 2014, Dr. Gideon Koren published a study in the American Journal of Obstetrics and Gynecology on the dangers of using Zofran while pregnant. The study included 900,000 Danish women and found that the use of Zofran led to a 30 percent increased risk of major congenital malformations. The popularity of the drug, which is due to the manufacturer’s  advertising techniques, becomes a frightening truth.

“The use of ondansetron for nausea and vomiting in pregnancy has increased from 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, despite unresolved issues regarding fetal safety and Food and Drug Administration warnings about serious dysrhythmias,” according to the study.

Dr. Koren encourages the use of doxylamine and pyridoxine to treat nausea, vomiting and other pregnancy-related symptoms.

Lawsuits Filed For Off-Label Promotion 

The pharmaceutical giant has settled a lawsuit with the FDA in addition to various civil suits. However, many are still pending.
Via: Express

In Louisiana, Alexis Alexander had started taking Zofran during her first trimester. She continued to use it for the remainder of her pregnancy. Her son was born in 2006 with congenital heart and lung defects. Alexander is just one of the many mothers who filed a lawsuit against the drug’s manufacturer.

In 2012, the company pleaded to criminal charges for off-label promotion of Zofran in a settlement with the FDA. GlaxoSmithKline paid $3 billion to resolve charges of unlawful promotion and failure to report safety data in the largest health care fraud settlement in U.S history. The company has also paid about $1 billion to settle civil lawsuits, but many are still pending.

As more research confirms that Zofran has a dangerous effect on unborn children, mothers are continuing to come forward to file lawsuits against pharmaceutical company GlaxoSmithKline.

Click here for an evaluation to see if you may be eligible for compensation.

The post Anti-Nausea Drug Zofran Linked To Birth Defects appeared first on Citizens Report.