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.

Alexis Benter

U.S. District Judge Joseph Goodwin said that it could take decades and cost millions of dollars in fees to try the more than 70,000 transvaginal mesh lawsuits that have been filed against seven pharmaceutical companies. Goodwin has urged the device makers and the claimants to work harder to resolve one of the biggest U.S. mass torts in history, but has vowed to send the suits to trial if need be.

Thousands of women have claimed the transvaginal mesh devices, which are used to treat stress urinary incontinence and pelvic organ prolapse, have caused painful infections, bleeding and other complications.

Your Legal Help

Intensive court-supervised meetings between key defendants Boston Scientific Corp, C.R. Bard and Johnson & Johnson’s Ethicon Inc. and lawyers for the women have led to no resolutions.

Bard, Ethicon and Boston Scientific have had the most claims filed against them, and have each been hit with multimillion dollar verdicts that have increased the pressure to settle. The companies, however, are standing behind their devices, denying all claims that they are defective. Lawyers for the three main companies are ready to prepare hundreds of additional cases for trial if need be.

Not all of the device makers are pushing for trials. American Medical Systems, a subsidiary of Endo International Plc, has already decided to settle, setting aside $1.6 billion to resolve 20,000 lawsuits. Danish company Coloplast A/S has also settled a sizeable amount of the nearly 2,000 mesh lawsuits brought against it.

If you or a loved one has suffered from infection, bleeding, or other side effects of a transvaginal mesh device, you may be able to seek medical compensation. Click here to receive a free case evaluation.

The post U.S. District Judge Says it Could Take Decades to Try Transvaginal Mesh Lawsuits appeared first on Citizens Report.