Zofran (ondansetron hydrochloride), which is manufactured by GlaxoSmithKline (GSK), is approved for use alone, or in combination with other medications, for the prevention of nausea and vomiting associated with chemotherapy and radiation therapy and is often used to prevent these symptoms following surgery. The medication works by blocking the body’s natural serotonin, which causes vomiting.
In 1991, the U.S. Food and Drug Administration (FDA) approved Zofran in the injectable form for the treatment of chemotherapy-induced nausea and vomiting. In 1995, oral Zofran tablet dosage was approved for the treatment of post-operative nausea and vomiting. Zofran oral disintegrating tablet (ODT) received approval in 1999. The first generic versions of Zofran were approved in 2006 with Sandoz marketing both the authorized generic for Zofran tablets and Zofran ODT. Other generic version of prescription Zofran are also now available.
Zofran and Morning Sickness and Zofran and Birth defects
Zofran is not approved for, but is often prescribed off-label to women suffering from morning sickness during pregnancy and has been associated with serious birth defects in the babies of women who took Zofran during their first trimester. Reported birth defects include Zofran heart defects including congenital heart malformations (heart defects) and oral clefts.
Zofran and its generics are often prescribed for pregnant women suffering from what is known as “hyperemesis gravidarum,” which is a serious form of morning sickness that is described as causing relentless vomiting that leads to significant loss of weight and dehydration, that may cause harm to the mother and fetus, if not treated. Although there are other, approved medications for morning sickness, a trend in prescribing Zofran, off-label, as the first line of defense has been seen.
The attorneys at our firm are investigating cases on behalf of individuals who experienced adverse health reactions, including congenital cardiac malformations, oral cleft and other birth defects following the maternal, in utero use of Zofran in the first trimester of pregnancy. If you or a loved one took Zofran during the first trimester and gave birth to a baby born with cardiac and/or cleft palate defects, or other adverse reactions associated with Zofran use, we urge you to contact one of our Zofran Pregnancy Birth Defects attorneys for a free consultation.
Since the approval of Zofran, our Zofran lawyers have heard from women whose babies suffered various adverse reactions after taking Zofran during the first trimester of pregnancy.
Multiple Studies Tie Zofran Use in Expectant Mothers to Serious Birth Defects in Babies
A number of studies have revealed an association between Zofran and birth defects, including an increased risk “for a cardiovascular defect and notably cardiac septum defect”. For example, according to a June 2014 report by The Toronto Star, Canadian women suffering with severe morning sickness are being prescribed Zofran. The drug is believed to be causing serious Zofran pregnancy birth defects in some babies according to the newspaper’s investigation, which also notes that Health Canada approved the drug for the treatment of nausea and vomiting in chemotherapy and surgery patients. In Canada, as in the U.S., Zofran is not approved for the treatment of nausea and vomiting in pregnant women, but is often prescribed off-label for these purposes. Information on the unapproved treatments is not publicly available from Health Canada; however the Star notes that GSK indicates that the drug is “not recommended” for use in pregnant women.
A Star analysis of a large review of the FDA’s public side effect reporting database of 2012 records revealed that no less than 20 Canadian women treated with ondansetron for vomiting in pregnancy reported serious suspected side effects, including the death of two babies and a number of cases of infants born with heart defects and kidney malformations. The analysis also revealed one baby born with a so-called “musculoskeletal anomaly” and that one doctor reported that ondansetron was the suspect culprit in a baby’s mouth deformity, jaundice, heart murmur, atrial septal defect (hole in the heart), and a second heart defect. Four babies were born weighing no more than four and a-half pounds and in six other cases, ondansetron was listed as potentially causing “fetal growth restriction.”
A study conducted in 2011 suggests that Zofran may increase the likelihood of babies being born with cleft palate by two-fold.
Although one study published in 2013 by the New England Journal of Medicine found that after tracking more than 600,000 Danish births via national birth and prescription registries, there was no significant increased risk of spontaneous abortion, stillbirth, or birth defect; another study released the same day by another group of Danish researchers revealed contradictory findings. The second study was based on the same national registries and reviewed nearly 900,000 births. In that study, a two-fold increase in heart defects was seen in babies born to women treated with ondansetron. The study was expanded to include more births and revealed the same findings.
In another study in which the teratogenic (disturbing the development of an embryo or fetus) risks associated with Zofran was studied, data from the Swedish Medical Birth Register and the Swedish Register of Prescribed Drugs were used to identify 1349 infants born to women who had taken ondansetron in early pregnancy from 1998 to 2012. The review revealed the presence of congenital malformations in babies in three national health registers. Risks for a cardiovascular defect and cardiac septum defect were increased and found to be statistically significant and an increased risk for a cardiac septum defect was found to be likely.
Another study entitled “Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects,” in which data from the National Birth Defects Prevention Study (NBDPS), a multi-site population-based case-control study, was used, revealed ties between Zofran and its generics to birth defects. Researchers examined nausea and vomiting in pregnancy and its treatment and associations with non-syndromic cleft lip with or without cleft palate, cleft palate alone, neural tube defects, and hypospadias. Of 4524 cases and 5859 control cases (more than 9,000 cases in all), nausea and vomiting of pregnancy was not observed to be associated with an increased risk of birth defects. What was seen was that potential risks were associated with three treatments, including ondansetron. The large study, published in 2012 in Birth Defects Research revealed that children diagnosed with cleft palate were 2.37 times likelier to be born of mothers who reported use of Zofran during the first trimester of pregnancy.
Alleged Off-Label Promotion of Zofran Led to Massive Settlement with the United States Government
In the U.S., it is illegal for drug manufacturers to promote any drug for uses not approved by the FDA; however, physicians may prescribe a drug for any purpose they see fit. This prescribing of medications for non-approved treatments is known as “off-label” use.
In the U.S., in 2012, the Department of Justice (DOJ) reached a $3 billion settlement with GSK following government allegations that the drug maker promoted the off-label use of a number of drugs, including Zofran. Court documents include allegations that GSK gave physicians kickbacks to prescribe Zofran for morning sickness, releasing bogus information about the drug’s safety and efficacy. GSK told the Star that under the settlement agreement, it admitted no wrongdoing “in connection with physician prescribing of Zofran in the U.S.” The United States also alleged that “this conduct caused false claims to be submitted to federal health care programs.”
If you or someone you know used Zofran in the first trimester of pregnancy and, thereafter, gave birth to a baby who was born with a birth defect, you (or someone you know) may have valuable legal rights and may be eligible to file a Zofran birth defect lawsuit. For a free case review, please fill out our online form to the right or call our office at 1-800-YOURLAWYER (1-800-968-7529) to speak to one of our Zofran Birth Defects attorneys.