Zofran – Citizens Report https://citizensreport.org a digital channel commited to health & medical rights. Wed, 17 Jan 2024 09:06:12 +0000 en-US hourly 1 https://wordpress.org/?v=4.9.24 https://citizensreport.org/wp-content/uploads/2016/12/cropped-cr-icon-1-32x32.png Zofran – Citizens Report https://citizensreport.org 32 32 Young Woman Files Against Zofran For Her Own Birth Defects https://citizensreport.org/2016/10/30/young-woman-zofran-birth-defect-lawsuit/ https://citizensreport.org/2016/10/30/young-woman-zofran-birth-defect-lawsuit/#respond Mon, 31 Oct 2016 02:03:12 +0000 http://www.citizensreport.org/?p=10801 An increasing number of women have filed lawsuits against GlaxoSmithKline, the pharmaceutical manufacturer of the anti-nausea drug Zofran. The majority of suits are filed by mothers who used Zofran while pregnant and gave birth to children with defects. In this case, a 20-year-old woman from Texas is suing the company for her own birth defects. The […]

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An increasing number of women have filed lawsuits against GlaxoSmithKline, the pharmaceutical manufacturer of the anti-nausea drug Zofran. The majority of suits are filed by mothers who used Zofran while pregnant and gave birth to children with defects.

In this case, a 20-year-old woman from Texas is suing the company for her own birth defects. The age of the plaintiff shows that Zofran has been prescribed to pregnant women for over two decades.

Using Zofran To Treat A Mother’s Morning Sickness

The plaintiff’s mother took Zofran to treat her severe morning sickness.
Image: The Pregnancy Zone

While pregnant, the woman’s mother dealt with a condition known as hyperemesis gravidarum. It’s a serious form of morning sickness characterized by excessive vomiting and intense nausea. During the first trimester, doctors prescribed Zofran to treat the debilitating symptoms.

Today, the 20-year-old woman suffers from congenital heart defects. She was born with a ventricular septal heart defect and pulmonary stenosis. She also has facial defects, such as cleft lip and cleft palate.

In the complaint, the woman argues that she has no genetic predisposition to cardiac or facial defects. She believes that Zofran exposure caused her defects and forever altered the quality of her life.

Filing A Suit For Compensation

The plaintiff was born with facial defects that require costly medical procedures.
Image: I Am Pregnant

On Nov. 30, 2015, the woman filed a lawsuit with the Northern District of California court system. She’s suing for negligence, fraud, misrepresentation and warranty breach.

The lawsuit alleges that GlaxoSmithKline discovered that Zofran might increase the risk of birth defects in 1992. But according to the complaint, the company didn’t take action and inform doctors of the risk.

GlaxoSmithKline engaged in off-label marketing of the anti-nausea drug, which the FDA approved for cancer patients only. The pharmaceutical company never did clinical studies before pushing the drug but reportedly knew that pre-natal Zofran exposure could injure unborn children.

Throughout her life, the 20-year-old woman had at least three surgeries. Doctors predict that she will need to undergo additional medical procedures for the remainder of her life. She’s suffered from permanent disfigurement, diminished quality of life, low self-esteem and physical and mental pain.

The woman seeks $75, 000 in compensation that would help to cover her medical bills. The award would also reimburse her for the purchase price of Zofran, and general, consequential and punitive damages.

If you or a family member was born with birth defects, then you might be entitled to compensation for this medical side effect.

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

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Alabama Parents Sue Pharmaceutical Company For Heart Problems Linked To Zofran https://citizensreport.org/2016/01/29/alabama-lawsuit-zofran-birth-defects/ https://citizensreport.org/2016/01/29/alabama-lawsuit-zofran-birth-defects/#respond Fri, 29 Jan 2016 17:11:29 +0000 http://www.citizensreport.org/?p=10324 In 1991, the Food and Drug Administration approved Zofran to treat the most severe kind of nausea. The drug was meant for cancer patients who required chemotherapy or radiation therapy. GlaxoSmithKline, the makers of Zofran, made the decision to engage in the off-label marketing of Zofran, touting it as “wonder drug” for morning sickness. A […]

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Family Files Lawsuit Against Zofran For Daughter's Cardiac Issues

An Alabama family is suing the makers of Zofran to gain compensation for daughter’s congenital birth defects that will require extended medical care and surgeries.

In 1991, the Food and Drug Administration approved Zofran to treat the most severe kind of nausea. The drug was meant for cancer patients who required chemotherapy or radiation therapy.

GlaxoSmithKline, the makers of Zofran, made the decision to engage in the off-label marketing of Zofran, touting it as “wonder drug” for morning sickness.

A family in Alabama is suing the makers of Zofran, alleging that they weren’t properly informed of the risks that led to their daughter’s birth defects.

Pre-Natal Zofran Exposure And Heart Defects

Ciara Legg’s daughter had open heart surgery before her first birthday.
Image: Adam

Ciara Legg used a generic version of Zofran to treat symptoms of morning sickness during her first and second trimester. She gave birth to a baby girl on Jan. 23, 2013. When her daughter was born, it was discovered that she suffered from congenital anomalies.

Legg’s daughter had open-heart surgery before her first birthday. She was only 8 months old. Doctors have said that she will need medical care and additional surgeries throughout her life.

The Legg family was never informed about Zofran’s potential to cause cardiac problems, which is the most common defect linked to the drug.  If she had been told about the drug’s potential to cause birth defects, Legg said she never would have taken it while pregnant. The family has since filed a lawsuit.

Taking Legal Action To Cover Medical Expenses

The Legg family is pursuing legal assistance in order to gain enough money to help cover their daughter’s medical bills.
Image: Bet

In the lawsuit, GlaxoSmithKline’s desire to have doctors prescribe the drug as a morning sickness medication is described as a “fraudulent marketing campaign.” The Legg family claims they weren’t properly informed of the risks associated with Zofran.

Because of the fact that their daughter will need additional surgeries down the line, the Legg family has decided to take legal action in an effort to gain “compensatory and punitive damages” and “equitable relief.” The money will be used to pay medical, incidental and hospital expenses.

“As a direct and proximate result of GSK’s conduct, the plaintiffs and their daughter have suffered and incurred harm including 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 the drug,” according to the legal complaint.

The drug manufacturer is allegedly aware of more than 200 children born with birth defects after their mothers used Zofran. Many families caring for a child with birth defects are struggling to afford the life-saving but costly medical procedures.

If you took Zofran while pregnant and if your child was born with birth defects, then you might be entitled to compensation for this medical side effect.

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

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Arkansas Family Files Against Zofran For Cleft Palate And Clubfoot Defects https://citizensreport.org/2016/01/19/zofran-suit-for-cleft-palate-and-clubfoot-defects/ https://citizensreport.org/2016/01/19/zofran-suit-for-cleft-palate-and-clubfoot-defects/#respond Tue, 19 Jan 2016 17:42:22 +0000 http://www.citizensreport.org/?p=10251 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” […]

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Mother Said Zofran Causes Cleft Palate And Clubfoot Birth Defects In Lawsuit

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.

 

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Mother Seeks Justice For Son’s Heart And Lung Problems Caused By Zofran https://citizensreport.org/2016/01/07/mother-launches-prayers-for-finn-and-takes-on-zofran/ https://citizensreport.org/2016/01/07/mother-launches-prayers-for-finn-and-takes-on-zofran/#respond Thu, 07 Jan 2016 20:01:21 +0000 http://www.citizensreport.org/?p=10149 Health professionals estimate 90 percent of pregnant women experience symptoms of nausea or vomiting. Kelly Blumenthal was no different. During the early stages of her pregnancy, Blumenthal began using a generic version of the off-label morning sickness drug Zofran in 2014. On January 2, 2015, her son was born with multiple heart defects, a lung defect and […]

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Family Sues Zofran Manufacturer in Birth Defects Lawsuit

A Virginia woman named Kelly Blumenthal has filed a lawsuit against Zofran, the morning sickness drug that allegedly caused her son’s severe heart defects.

Health professionals estimate 90 percent of pregnant women experience symptoms of nausea or vomiting. Kelly Blumenthal was no different.

During the early stages of her pregnancy, Blumenthal began using a generic version of the off-label morning sickness drug Zofran in 2014.

On January 2, 2015, her son was born with multiple heart defects, a lung defect and an intestinal issue. In addition to developing a program to support others dealing with similar circumstances, Blumenthal has filed a suit to fight against the drug that changed her family forever.

A Son’s Birth Defects, A Mother’s Broken Heart

Blumenthal’s son suffers from atrioventricular canal defect, which caused holes to develop in the center of his heart.
Image: Hx Benefit

Although doctors believed he wouldn’t make it through the pregnancy, Blumenthal’s son pushed through. However, she knew his life wouldn’t be easy. Originally planning to name him Landon, Blumenthal decided to change his name to Finley, meaning “warrior.”

Blumenthal’s son came into the world with a list of congenital problems, but the most severe is called atrioventricular canal defect. The diagnosis means that Finn has a hole in the center of his heart.

The condition affects the natural regulation blood flow and requires costly open heart surgeries. If untreated, the condition can cause serious complications including enlargement of the heart, heart failure, pulmonary hypertension, and pneumonia. Finn had open heart surgery before his first birthday.

Additionally, Finn has a double outlet right ventricle defect. The condition involves a difference in the structure of the heart, causing the two main arteries to connect to only the right chamber rather than both pumping chambers.

Blumenthal’s 1-year-old boy also suffers from  heterotaxy of the lungs, which is a misalignment of these essential organs in the chest. Finn’s lung has been deteriorating, and his mother needs to constantly monitor his blood oxygen levels. The heterotaxy is likely also linked to Finn’s malrotation of the intestines, in which his small bowel is found on the right side of the abdomen.

Supporting Others And Fighting The Industry

In addition to pursuing legal assistance to get compensation for Finn’s medical expenses, Blumenthal created a support group for families with sick children.
Image: Fredericksburg

There is no doubt that Blumenthal’s heart was broken when she discovered her son suffered from so many medical problems.  Finn’s short life has been filled with expensive surgeries, endless tubes, heavy oxygen tanks and long nights in the hospital.

Through a Facebook page called Prayers for Finn, Blumenthal has created a community of over 26,000 members that offers mutual support and comforting donations to families with sick children. It has been instrumental in helping her get through the surgeries.

On September 28, 2015, Blumenthal took another action. She decided to fight against the drug that allegedly caused her son’s medical issues. She named Glenmark Generics Inc., USA and GlaxoSmithKline LLC in her complaint, taking on both companies that may have had a hand in causing her son’s condition.

But Blumenthal is not alone. Hundreds of lawsuits have been filed against the manufacturer of Zofran, with about 200 cases consolidated in a multi-district litigation in Boston.

If you took Zofran while pregnant and if your child was born with birth defects, then you might be entitled to compensation. Complete a free, no obligation case evaluation now to see if you qualify.

 

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Massachusetts Takes On All Zofran Cases https://citizensreport.org/2015/11/25/massachusetts-zofran-lawsuits/ https://citizensreport.org/2015/11/25/massachusetts-zofran-lawsuits/#respond Wed, 25 Nov 2015 20:41:56 +0000 http://www.citizensreport.org/?p=9703 Zofran, an anti-nausea drug that may have been misprescribed to treat pregnant women, can cause severe and debilitating birth defects. Children exposed to Zofran can suffer from heart problems, cleft lips/palates and craniosynostosis. Mothers who took Zofran while pregnant have been seeking justice against the manufacturer, claiming that the drug was illegally marketed to pregnant […]

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Zofran Consolidated to Multi-District Litigation in Massachusetts

Individual lawsuits filed by families injured from the anti-nausea drug Zofran will be combined into a multi-district litigation in Boston, Massachusetts.

Zofran, an anti-nausea drug that may have been misprescribed to treat pregnant women, can cause severe and debilitating birth defects. Children exposed to Zofran can suffer from heart problems, cleft lips/palates and craniosynostosis.

Mothers who took Zofran while pregnant have been seeking justice against the manufacturer, claiming that the drug was illegally marketed to pregnant women for off-label use.

Last month, these lawsuits were combined into a multi-district litigation (MDL) that will be examined in Boston. It seems that families injured by Zofran may finally get justice.

Centralizing Zofran Cases In A Multi-District Litigation

Lawsuits filed in 10 states, and potentially 22 others, are set to be tried in Boston.
Image: My Money Coach

In an MDL, all federal civil cases with similar claims will be transferred to one court. Zofran suits will be consolidated in a District Court of Massachusetts. The multi-district litigation suit has been given the number MDL No. 2657.

The Boston team will prepare the steps to take the cases to trial, with Judge F. Dennis Saylor collectively examining the evidence. He will be managing the often costly pretrial and discovery process.

“Judge Saylor is an experienced transferee judge who we are confident will steer this litigation on a prudent course,” according to the court transfer order.

The court will be addressing the claim that Zofran causes birth defects and the kinds of defects it causes. The case will also focus on the role of the manufacturer GlaxoSmithKline in promoting the drug as a morning sickness treatment, additionally questioning if the company should have included warnings about birth defects.

Although witnesses will only have to testify once, an MDL is different from a class-action suit. The cases will remain individual in nature, and each family will be treated as a separate entity.

There was debate as to where the MDL would be conducted. The state Massachusetts was chosen to “serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation,” according to the court transfer order.

More information about the decision to consolidate can be found in the transfer order published on October 13, 2015.

Benefits Of A Consolidated Process

An MDL is cheaper and easier to litigate because it coordinates resources.
Image: Under 30 CEO

The Zofran multi-district litigation is meant to save time and money. Overall, it will make the process more effective and economical by conserving judicial resources and creating consistency in pretrial rulings.

“Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary,” according to the transfer order.

While plaintiffs who have already filed a lawsuit against GlaxoSmithKline await the decision,  families injured by Zofran can still take action and file a suit.

If you took Zofran while pregnant and your child was born with birth defects, you might be entitled to compensation for this medical side effect.

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

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Extreme Morning Sickness Is A Serious Condition https://citizensreport.org/2015/10/22/extreme-morning-sickness/ https://citizensreport.org/2015/10/22/extreme-morning-sickness/#respond Thu, 22 Oct 2015 22:41:34 +0000 http://www.citizensreport.org/?p=8959 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 […]

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Effects And Causes Of Severe Morning Sickness During Pregnancy

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

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Anti-Nausea Drug Zofran Linked To Birth Defects https://citizensreport.org/2015/08/20/zofran-nausea-birth-defects/ https://citizensreport.org/2015/08/20/zofran-nausea-birth-defects/#respond Thu, 20 Aug 2015 16:00:25 +0000 http://www.citizensreport.org/?p=6730 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 […]

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GlaxoSmithKline's Cancer Drug Zofran Linked To Congenital Disorder

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.

 

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