Zofran Birth Defects Lawsuits Continue With Timeline of Events Including Recall


Zofran Birth Defects Lawsuits Allege That Zofran Is Associated With Cleft Palate, Cleft Lip, Heart Murmur, And Other Defects In Newborns Whose Mothers Were Prescribed The Drug To Treat Severe Morning Sickness.

Zofran-Birth-Defects-Lawsuit-Wright-and-Schulte-LLCThe attorneys at Wright & Schulte LLC are investigating claims in Zofran birth defects lawsuits that allege the anti nausea medication caused birth defects when used in the use of Zofran during the first trimester of pregnancy to treat severe morning sickness. The Zofran lawsuits filed in Massachusetts and Pennsylvania purport that Zofran manufacturer, GlaxoSmithKline (GSK) failed to warn physicians and their patients about the risk of birth defects associated with the medication and “illegally and fraudently” promoted Zofran as a treatment to morning sickness to pregnant women without receiving approval for that use from the U.S. Food and Drug Administration. (1:15-cv-10429, U.S. District Court, District of Massachusetts; 2:15-cv-00709, Eastern District of Pennsylvania) “the attorneys believe that investigating these allegations is important for expectant mothers who relia on the drug companies compliance and assertion that their prescription medications are safe for them and their unborn babies” – Wright & Schulte LLC

The U.S. Food and Drug Administration (FDA) approved Zofran to treat nausea and vomiting induced by chemotherapy, radiation and surgery. However, the U.S. Department of Justice claims that GSK promoted the off-label use of Zofran for treating morning sickness in pregnant women when the medication was only approved for post-operative nausea. There is no documentation found where the FDA approved Zofran for use in pregnant women.
[fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm310219.htm, June 29, 2012]
[justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report, July 2, 2012]

The attorneys at Wright & Schulte LLC are investigating Zofran birth defects lawsuits alleging birth defects due to Zofran use during the first trimester of pregnancy to treat severe morning sickness. The U.S. Food and Drug Administration (FDA) has not approved Zofran use during pregnancy because the risk to a fetus is not known based on animal reproduction studies and studies on pregnant women. Zofran’s manufacturer, GlaxoSmithKline pleaded guilty and paid $3 billion to settle criminal and civil allegations that included promoting Zofran for unapproved uses such as treating morning sickness.

“Studies have shown that babies are born with birth defects such as cleft lip, cleft palate, heart defects, including a hole in the heart,” says Wright & Schulte LLC. “We are offering free, no-obligation lawsuit evaluations to families whose baby experienced these and other Zofran birth defects after the mother was prescribed the nausea medication.”
[accessdata.fda.gov/drugsatfda_docs/label/2010/020007s040,020403s018lbl.pdf, May 10, 2010]
[justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report, July 2, 2012]

In December of 2014 a study was conducted by Swedish researchers and found that Zofran increased risks for a cardiovascular defect, notably a cardiac septum defect (hole in the heart) in babies whose mothers used Zofran to treat severe morning sickness in early pregnancy.

In August of 2013 another study conducted by Danish researchers was presented at the International Society of Pharmacoepidemiology meeting in Montreal and found women who used Zofran during the first trimester of pregnancy to treat severe morning sickness are at a higher risk of having babies born with major congenital heart defects.

In January through March of 2013 the FDA issued new safety information regarding Zofran and it’s potential to cause serotonin syndrome, a life-threatening event that occurs when drugs that affect a person’s serotonin level are taken at the same time.

On December 4th of 2012, the FDA announced a Zofran recall, stating that the 32 mg, single intravenous dose of Zofran was recalled due to the potential for QT interval prolongation, an irregular heart rhythm which can lead to Tosades de Pointes, an abnormal and potentially fatal heart rhythm.

On July 2nd of 2012: The U.S. Department of Justice (DOJ) announced that GlaxoSmithKline plead guilty to federal charges they violated the Food, Drug, and Cosmetic Act. In addition GSK agreed to pay $3 million in whistleblower charges that the Zofran manufacturer promoted several drugs, including Zofran for off-label use in expectant mothers and paying kickbacks to doctors to prescribe certain of the company’s drugs. According to the DOJ, the resolution is “the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.”

On June 29th of 2012, the FDA provided the preliminary data from GlaxoSmithKline’s clinical study showing 32 mg single intravenous dose of Zofran and its generics may affect the electrical activity of the heart (QT interval prolongation), which could predispose patients to develop Tosades de Pointes, an abnormal and potentially fatal heart rhythm.

On June 29 of 2012, GlaxoSmithKline changed its Zofran drug label to remove the 32 mg single intravenous dose. The updated safety label advises a maximum of 16 mg per dose.

In January of 2012, the Center for Birth Defects Research and Prevention’s study found taking Zofran during the first trimester of pregnancy could double the risk of a baby being born with a cleft palate.

On September 15th of 2011 the FDA announced that Zofran use may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm known as Torsade de Pointes.

The FDA requires GlaxoSmithKline to “conduct a thorough QT study to assess the potential for the drug to prolong the QT interval.”

September 15, 2011: GlaxoSmithKline revises Zofran safety label to warn patients with congenital long QT syndrome to avoid using the medication because they are at risk for Torsade. Label revision also included recommended ECG monitoring for patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias, or those taking other medications that can lead to QT prolongation.

On December 7, 2006, the FDA approves the first generic versions of Zofran tablets and oral solution used to prevent nausea and vomiting associated with surgery, radiation and cancer chemotherapy.

On March 9, 1999, the FDA sends warning letter to GlaxoWellcome saying its promotional materials for Zofran injection are “false or misleading because it lacks fair balance” and “fails to present any information regarding the risks associated with the drug.”

In February of 1999, the FDA approves Zofran ODT, an orally disintegrating tablet.

In April of 1995, the FDA approves Zofran in oral dosages form to treat nausea and vomiting in surgery patients.

On January 4th of 1991: FDA approves Zofran (ondansetron) in injection form for treating nausea and vomiting induced by chemotherapy.

About Wright & Schulte LLC

Wright & Schulte LLC, an experienced personal injury firm, is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free Zofran lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.

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