News on U.S. government agencies, U.S. politics, companies doing business with U.S. federal government. Read U.S. national and local news. This site is not affiliated with United States Government.
Zofran Birth Defect Studies Show Risks When Used For Morning Sickness
(USGovernment-News.Com, February 28, 2015 ) Columbus, OH --Wright & Schulte LLC reports that Danish researchers have found that women who use Zofran during the first trimester of pregnancy to treat a severe form of morning sickness called hyperemesis gravidarum, are at a higher risk of having children born with major congenital heart defects. The Zofran birth defects studies involved 897,018 Danish women who gave birth between 1997 and 2010. Of the 1,248 women who filled a prescription for ondansetron (the generic name of Zofran) in the first trimester, 58 women (4.7 percent) had babies with a congenital malformation, compared to 31,357 women (3.5 percent) who did not use ondansetron. According to the study, women who were exposed to ondansetron were at a 30 percent increased risk for having a baby with major congenital heart defects. The results were presented in August 2013 at the International Society of Pharmacoepidemiology meeting in Montreal.
Besides heart defects, the use of Zofran during pregnancy can also double the risk of a baby being born with a cleft palate, according to a study from the Centers for Birth Defects Research and Prevention. Based on the Toronto Star’s examination of the U.S. Food and Drug Administration’s (FDA) database, other Zofran side-effects reported include:
• Fetal growth restriction
• Jaundice
• Kidney malformation
• Death
[onlinelibrary.wiley.com/doi/10.1002/bdra.22865/abstract, November 19, 2011]
[thestar.com/news/gta/2014/06/25/birth_defects_blamed_on_unapproved_morning_sickness_treatment.html, June 25, 2014]
Wright & Schulte LLC offers free, no-obligation Zofran lawsuit evaluations to parents and families whose child experienced Zofran birth defects after taking the nausea medication, including heart defects, cleft lip and cleft palate. To speak with one of the firm’s attorneys, call 1-800-399-0795 or visit yourlegalhelp.com for more information on this and other harmful drugs.
Zofran was approved by the FDA in 1991 to treat nausea and vomiting in chemotherapy, radiation and surgery patients. The FDA has not approved Zofran to treat morning sickness in pregnant women. Zofran is in a class of medications called, 5-HT3 receptor antagonists, that work to block serotonin, a natural substance that may cause nausea and vomiting. Pregnant women who take Zofran are also at risk of health complications. In June 2012, the FDA warned that Zofran may affect the electrical activity of the heart which could lead to patients developing an abnormal and potentially fatal heart rhythm. In 2014, the FDA ordered a change to the safety labels of Zofran and other 5-HT3 receptor antagonists to add that the drugs could potentially cause serotonin syndrome, a life-threatening event that occurs when other drugs that affect a person’s serotonin level are taken at the same time.
[fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm310219.htm, June 29, 2012]
[fda.gov/Safety/MedWatch/SafetyInformation/ucm418818.htm, October 16, 2014]
GlaxoSmithKline, the U.K.-based manufacturer of Zofran, was cited by the U.S. Department of Justice (DOJ) for illegally promoting Zofran to treat morning sickness in pregnant women. In addition to Zofran, the DOJ charged the company with improperly promoting its other drugs and paying kickbacks to doctors who prescribed GSK’s drugs. GSK agreed to pay $3 billion to resolve the DOJ’s civil and criminal cases brought against the company. According to the DOJ, the GSK cases were the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.
[justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report, July 2, 2012]
Court records indicate that Zofran birth-defects lawsuits are being filed on behalf of families whose babies have been born with birth defects. For instance, one lawsuit was recently filed against GlaxoSmithKline (GSK) on behalf of a mother who took Zofran to treat morning sickness during the first trimester of pregnancy. According to the lawsuit, the baby was born in 2000 with numerous congenital defects, including an atrial septal defect, and was also diagnosed with facial dysmorphia, low set ears, hearing loss, and webbed toes. The Zofran lawsuit states that the child has undergone 10 surgeries in 12 years to correct the numerous congenital abnormalities. The Zofran lawsuit accuses GSK of promoting Zofran to pregnant women without receiving approval from the FDA and without conducting “a single clinical trial” in pregnant women. (1:15-cv-10429, U.S. District Court, District of Massachusetts)
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.
We are pleased to offer you this exciting, new, and entirely free professional resource. Visit our Free Industry resource center today to browse our selection of 600+ complimentary Industry magazines, white papers, webinars, podcasts, and more. Get popular titles including:
