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.

Extreme morning sickness, also known as hyperemesis gravidarum, is a dangerous condition that impacts both the mother and her unborn baby.

Dealing with morning sickness is an expected part of having a baby. About 70 to 80 percent of women experience mild morning sickness during pregnancy.

But there’s another kind of morning sickness that it is not often publicized. Hyperemesis gravidarum is an extreme form of morning sickness that causes severe nausea and vomiting.

Effects of Severe Morning Sickness

Women who suffer from extreme morning sickness deal with constant debilitating nausea throughout their pregnancy.
Image: Healthline

Hyperemesis gravidarum has been linked to a pregnancy hormone called human chorionic gonadotropin (HCG). The hormone is created in the placenta to assist in providing nutrients for the baby during pregnancy.

The hormone is produced rapidly early in pregnancy, usually in the first three months. The hormone doubles every 48 to 72 hours and increases throughout the duration of the pregnancy.

Standard morning sickness and hyperemesis gravidarum are separate conditions with distinct symptoms that require very different treatments. Extreme morning sickness is more likely to develop when the mother is pregnant with more than one child, or if she has a hydatidiform mole.

A hydatidiform mole is a type of gestational trophoblastic disease (GTD) that forms a growth inside the womb at the beginning of a pregnancy.

Morning sickness is characterized by:

• nausea that is sometimes accompanied by vomiting
• nausea that subsides after 12 weeks
• vomiting that does not cause severe dehydration

Hyperemesis gravidarum is characterized by:

• nausea that does not subside
• nausea accompanied by severe vomiting
• vomiting that causes severe dehydration and does not allow you to keep any food down
• vomiting more than three or four times per day
• becoming dehydrated
• feeling light-headed or dizzy
• losing more than 10 lbs. or five percent of your body weight due to vomiting
• constant nausea

A Common Condition

Kate Middleton was hospitalized because the severity of symptoms caused by extreme morning sickness.
Image: Express

No one is exempt from the effects of extreme morning sickness. Even Kate Middleton, the wife of Britan’s Price William and the Duchess of Cambridge, dealt with hyperemesis gravidarum.

While she was pregnant with her second child, Middleton suffered from hyperemesis gravidarum. She experienced violent vomiting and weight loss during the early stages of both of her pregnancies. The effects were so severe that she had to be hospitalized.

If untreated, severe morning sickness can cause dehydration, poor weight gain, and social or psychological problems. Women may not gain sufficient weight during pregnancy, which is a threat to the development of the fetus.

While the condition is extremely dangerous, there are many drugs used to manage its symptoms.

Treating Extreme Morning Sickness

Doctors may prescribe anti-nausea medications to relieve symptoms of extreme morning sickness. Many, such as Zofran, could cause serious side effects.
Image: Babble

The severity of the morning sickness may decrease if the mother eats small, frequent meals and dry foods such as crackers.

While dealing with extreme morning sickness, pregnant women should drink a lot of fluids, especially during times when nausea isn’t present. Good examples of fluids other than still water include seltzer, ginger ale, or other sparkling waters. Some women must be admitted to the hospital to receive fluids if dehydration worsens.

In addition, women can take Vitamin B6 (no more than 100 mg daily) to help with nausea. However, in some cases, doctors may prescribe anti-nausea medicine.

Zofran, often used to treat extreme morning sickness, can be a great remedy for some women. The drug was originally used for cancer patients with extreme nausea from cancer treatments like chemotherapy and radiation.

However, Zofran has been associated with a variety of birth defects. It has caused cleft lips, cleft palates, club feet, craniosynostosis and congenital heart and lung problems in newborns.

If you took Zofran while pregnant and your child was born with birth defects, you could be entitled to medical compensation. Click here for a free case evaluation

The post Extreme Morning Sickness Is A Serious Condition appeared first on Citizens Report.

A new study shows women who are diagnosed with cancer while pregnant may be able to receive treatment without harming the fetus.

Cancer treatments are taxing on the body, and it seems like it would be nearly impossible to grow and nurture a life while receiving weekly doses of chemotherapy.

Deciding how to deal with a cancer diagnosis while pregnant is one of the most difficult choices a woman has to make. Medical professionals are equally as perplexed. Advice varies, with some doctors suggesting early delivery and others recommending termination.

A new study shows that undergoing cancer treatment while pregnant may not harm the fetus.

The Study

Researchers conducted a neurological test on 129 children and found that they had normal cognitive and cardiac functioning.
Image: River Valley Pediatrics

The study, published in The New England Journal of Medicine, was presented to the European Cancer Congress in Vienna. It included 129 children who had mothers that underwent cancer treatment while pregnant.

The children were exposed to chemotherapy, radiation or surgery during the last two trimesters.

After birth, the researchers conducted a neurological test, called the Bayley Scales of Infant Development, at 18 months and 3 years of age. The exam showed the children had normal cognitive and cardiac functioning.

“We didn’t find any difference in cardiac functioning or cognitive function between children exposed to cancer treatment in utero and the control group,” said Dr. Frédéric Amant, the lead author of the study and a professor of obstetrics and gynecology at the Katholieke Universiteit Leuven in Belgium.

“To some extent, it’s surprising because cancer treatment is quite toxic and we know most chemotherapy drugs cross the placenta,” he said.

The mothers didn’t go through chemotherapy during the first trimester because a heightened risk of birth defects is associated with that period. Mental development is less likely to be affected by cancer treatments later in pregnancy.

The mothers included in the study had various types of cancer. A vast majority were diagnosed with breast cancer, whereas 16 percent had blood cancers.

“The main message of this study is that termination of pregnancy is not necessarily warranted, and that early preterm delivery to be able to do cancer treatment isn’t warranted, either,” said Dr. Elyce H. Cardonick, a maternal-fetal specialist at Cooper Medical School of Rowan University.

The Problem of Prematurity

Cancer treatment did not affect the newborns, but prematurity was associated with decreased cognitive abilities.
Image: Parent Map

For mothers with cancer, more than 60 percent of children were born earlier than 37 weeks. In comparison, only 8 percent of healthy mothers have premature births.

The majority of mothers had induced labor in order to continue cancer treatment, but Dr. Amant wants to stop this practice. He hopes the study’s findings will help persuade doctors to allow full-term births.

The premature babies were matched with a control group of children of the same age born to mothers without cancer. While the amount of chemotherapy sessions did not impact the cognitive functioning of children, the degree of prematurity did.

Prematurity was associated with lessened cognitive abilities in both study groups. The authors took factors like parental education into account, but still found that more time spent in the womb added two more points on the Bayley test.

“Prematurity is a problem for these children, but chemotherapy is not,” Dr. Amant said.

Chemotherapy treatments use a chemical called doxorubicin, which has been known cause damage to adult hearts in specific doses. The researchers studied the hearts of 47 of the 129 children in the study using electrocardiography and echocardiography.

Researchers found no difference in the size of the heart chambers or the muscle’s ability to pump blood.

At age 3, “the cardiac development of these babies was pretty normal,” said Dr. Michael F. Greene, the chief of obstetrics at Massachusetts General Hospital.

Limitations Of The Study

Although researchers would like the study to be met with cautious optimism, they still hope that it will influence medical decisions about cancer treatment and pregnancy. 
Image: Atlanta Black Star

Dr. Greene expressed cautious optimism about the results, but assures pregnant women undergoing cancer treatment that “it’s not inevitably a horrible problem for their offspring.”

However, the study did not include all chemotherapy drugs and left out targeted anticancer drugs. The study is limited by the rarity of women who receive a cancer diagnosis while pregnant, which only happens in one of every 1,000 pregnancies.

“This paper has very detailed standardized follow-up on children,” Dr. Cardonick said, adding that the multi-center study would provide valuable information to physicians and patients.

Dr. Cardonick, who tracks cancer and pregnancy, has heard of a couple of “sad cases” where “a patient was denied cancer treatment during pregnancy, and died soon after the baby was born, because there was no confidence that cancer treatment during pregnancy would be tolerated by the fetus.”

It is hard to say whether doctors will take the study results into account, but hopefully it will be able to allow the women facing the decision to rest easier.

The post The Effects Of Undergoing Cancer Treatment While Pregnant 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.