The first legal challenge in a Zofran heart rhythm lawsuit involves allegations that the drug caused severe cardiac defects in a pregnant woman. One such case was filed by an Alabama mother in June 2015. Her daughter was born with a severe congenital heart defect and had open heart surgery at age four. She was also implanted with a pacemaker at age 11 and will likely need multiple surgical procedures throughout her life. These cardiac defects were caused by the drug’s use during pregnancy.

Torsade de Pointes

An irregular heart rhythm caused by a medication called Zofran is called Torsade de Pointes. This condition is caused by a prolongation of the QT interval, a measure of the time between a heart’s Q wave and its T wave. Typically, this interval is between 350 and 440 milliseconds. Zofran causes this interval to be longer and can cause a potentially life-threatening arrhythmia known as torsade de points. The dangerous condition is characterized by rapid heartbeat, shortness of breath, dizziness, and chest pain.

The FDA issued an initial safety warning for Zofran in Sept. 2011 after reports linked the medication to abnormal heart rhythm. The FDA specifically warned physicians against prescribing Zofran to patients with pre-existing heart conditions like ventricular fibrillation and long QT syndrome. This new warning also notified the drug’s manufacturer, GlaxoSmithKline, to do a thorough study and reposition the warning label.

QT prolongation

The Zofran QT prolongation lawsuit is a result of the drug’s adverse effects, a condition known as QT prolongation. Zofran, manufactured by GlaxoSmithKline, was approved by the FDA in 1991 as a treatment for nausea in children and pregnant women. In 2011, the FDA issued a warning regarding the drug’s risk of causing QT prolongation. QT prolongation is a type of heart rhythm disorder that can result in a chaotic, erratic heartbeat.

Several years ago, plaintiffs filed a class-action lawsuit in the U.S. District Court of Massachusetts alleging QT prolongation. This is a rare heart condition and requires corrective surgery. Plaintiffs alleged that the drug causes QT prolongation, but they did not specify which medications are involved. Despite these claims, the number of lawsuits relating to Zofran is expected to grow substantially in the future.

Torsade de Pointes symptoms

Torsade de Pointes is a life-threatening abnormal heart rhythm characterized by spikes that point downward. Researchers are not certain why the spikes look like this, but they are more frequent and more severe than normal. A Torsade de Pointes episode causes a significant drop in blood pressure, leading to dizziness and fainting. If not treated immediately, a person may die from ventricular fibrillation.

Another risk posed by Zofran is the prolongation of the QT interval, the time between the contraction of muscles and recovery. This prolongation of the QT interval can cause a serious and life-threatening abnormal heart rhythm called torsade de points. Often, this condition leads to fainting, coma, or even death. As a result, Zofran users should consult a doctor right away to avoid the drug.

GSK’s denials of miscoding

The plaintiffs in the Zofran Abnormal Heart Rhythm lawsuit allege that the manufacturer of the drug, GSK, failed to warn patients of the risks of the drug during pregnancy. If the drug had been known to cause such defects, the manufacturer should have provided a warning to women who used it during pregnancy. The failure to do so could result in tort liability under state law. Plaintiffs also claim that the FDA approved the drug based on incomplete information and material misrepresentations. The FDA did not address the animal studies proving that Zofran poses a fetal risk.

In response to the plaintiffs’ claims, GSK filed a citizen petition with the FDA to require the agency to include the risks of pregnancy on Zofran’s label. GSK’s attorneys met with the FDA and provided them with the necessary safety information. The FDA declined to require a label change and rejected GSK’s request. The lawsuit will now proceed to trial.

Taking Zofran while pregnant

A new lawsuit alleges that the use of Zofran while pregnant is causing the development of abnormal heart rhythms and birth defects in babies. The lawsuit alleges that the drug’s maker, GSK, failed to warn the public about the risks of Zofran during pregnancy and hid these dangers from consumers. While GSK denied that Zofran was linked to abnormal heart rhythms, plaintiffs contend that the drug maker withheld relevant information from the FDA and failed to provide adequate warnings to the public.

The FDA, however, was made aware of the dangers of Zofran while pregnant in 2015, and in response, asked GSK to submit supplemental information to the agency. In response to the citizen petition, the company submitted a proposal to change Zofran’s label, warning consumers against taking the drug during pregnancy. The new label included a warning about the risks to an unborn baby if taken while pregnant.

Compensation available for birth defects caused by Zofran

If you or a loved one developed a birth defect after taking Zofran, you may be entitled to compensation for the injuries caused by the drug. If you or a loved one has experienced serious side effects from Zofran, you should consult with a qualified lawyer who has extensive experience in handling birth defect cases. Terry Bryant is an experienced attorney who has helped countless people obtain compensation after suffering from birth defects caused by drugs.

As a mother who has had to deal with the aftermath of Zofran, you likely don’t want to take the next step – filing a Zofran lawsuit. However, if your child has suffered heart defects, birth defects, or a cleft palate, you can pursue compensation for your child’s condition. Moreover, if you have children suffering from birth defects, you can file a birth defect lawsuit and seek compensation from the responsible party.

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