|November 5, 2013 - Coroner rules Bimbo Onanuga (pictured above) died by 'medical misadventure'|
Is induction of labour with Cytotec (Misoprostol) worth the risk?
AIMS Ireland welcomes the verdict of ‘medical misadventure’ delivered in the Dublin Coroner’s Court in the case of Bimbo Onanuga, who died in the Rotunda Maternity Hospital in March 2010. The term ‘medical misadventure’ means that Bimbo Onanuga died of “an unintended result of an intended action” (RTE TV News, November 5, 2013). The Coroner welcomed changes in practice that had taken place in the Rotunda since Bimbo’s death but he also questioned various medical witnesses on the drug Cytotec (Misoprostol) and its off label use for induction of labour. While the administration of Cytotec will not be recorded as a cause of death in the case of Bimbo - or any other woman or baby who dies after being exposed to this 'off label' drug - it is still worthy of note that the Coroner's inquest focused on its use for induction of labour in Ireland and questioned the safety and efficacy of its 'off label' use.
Cytotec (Misoprostol) is a drug that is indicated for use in reducing gastric ulcers. It also has the side effect of producing uterine contractions and after it was approved by the FDA in the USA, it began to be used ‘off label’ for induction of labour in maternity services. This ‘off label’ use of approved medications is supported by the FDA and other similar medicines agencies worldwide as long as this use is based on sound medical evidence.
A Cochrane review in 2010 of ‘Vaginal Misoprostol for cervical ripening and induction of labour’ raised serious questions about the evidence that supports ‘off label’ use of misoprostol. This review posits that what is of particular concern in the ‘off label’ use of misoprostol are “several reports of uterine rupture following misoprostol labour induction with and without previous caesarean section”. It also suggests that “in countries in which misoprostol is being used for non-registered obstetric indications, there is a need for health authorities and professional organisations to clarify the medico-legal implications”. In other words, it is of great importance that health authorities, such as the HSE. publish clear guidelines for practitioners to ensure the safety of a drug - particularly one that lacks well designed clinical trials that support efficacy and safety of use.
In an article called The Freedom to Birth - The Use of Cytotec to Induce Labour: A Non-Evidence Based Intervention published in the Journal of Perinatal Education (2009) the author, Madeline Oden, discusses the need to be aware of the evidence-based interventions that are used in childbirth. The American College of Obstetricians and Gynecologists (ACOG) makes recommendations that have become the standard of care for labor and birth and Oden expalins that these recommendations sometimes deviate from the evidence-based ones supported by published research. The routine practices of episiotomies, induction, and denying food to the mother during labor without true medical indication have all been shown to be unnecessary interventions and can contribute to a spiraling effect of adverse events up to and including deaths of the mothers and/or infants. The off-label use of Cytotec (misoprostol) to induce labor and soften the cervix is an excellent example of an unnecessary intervention that is not supported by research (Enkin et al., 2000) (see Table) yet is rapidly becoming the standard of care, despite the evidence demonstrating the catastrophic events that can occur when it is used.
A Mother’s story - Madeline Oden discusses her experience of Cytotec
In December 2001, my 32-year-old daughter, Tatia Oden French, entered a well-known hospital in Oakland, California, to have her first child. She was in perfect health. The baby was in perfect health. The pregnancy was “unremarkable.” Tatia was almost 2 weeks past the due date, and the doctor wanted to induce her. After much stalling on Tatia's part, she reluctantly agreed to submit to induction. The agent used was Cytotec (misoprostol). None of the medical staff told us anything about Cytotec. When I asked what Cytotec was, I was told it is “the standard of care… we use it all the time.” Tatia said it was “not approved by the FDA [U.S. Food and Drug Administration] for use in labor.” Nothing else was said about the potential side effects, the dangers to the mom and child, or the alternatives. However, phrases such as “You don't want to go home with a dead baby, do you?” were said. The pressure was on. Tatia conceded. She told me to go home and that she would call me, believing it would be a long night. We told each other we loved each other and, having not decided on which specialty she would focus on in medical school, she smiled and said, “Maybe I'll be an OB/GYN.”
Ten hours after Tatia was induced with Cytotec, both she and her baby girl, Zorah, were dead. When I asked Tatia's doctor what happened, she just said, “It was a very rare adverse effect of Cytotec, but it does happen.” Still not comprehending what had just happened, I heard myself ask the doctor, “Could you at least tell me that you will not use that drug again?” Surprised, she looked at me and said, “No, I cannot promise that.” Finally, my two sons, Tatia's dad, Tatia's husband, and I were allowed into the operating room where Tatia and Zorah were lying perfectly still. We gathered and said a prayer around both of them. When I left the hospital, it was raining and gray and cold. I heard myself say out loud, “That drug is going to go away.”
After her daughter’s untimely death, Madeline Oden began to campaign for the cessation of the use of Cytotec for the induction of labour. She founded the Tatia Oden French Memorial Foundation in an effort to empower women around the issues of childbirth and pregnancy. The main focus of the foundation is on maternal mortality, ‘off label’ use of drugs, such as Cytotec, and informed consent. The danger of using a drug like Cytotec as an ‘off label’ medication is that no accurate statistics are kept on adverse events when it is used to induce labor. Oden says: “Pregnant women are still being given Cytotec, and some come through unscathed. However, many women and babies are permanently harmed.”
For more information about The Tatia Oden French Memorial Foundation, log on to the organization's Web site (http://www.tatia.org/)
For more information on Bimbo Onanuga and the AIMSI campaign to have her case heard at the Coroner’s Court, see http://nocountryforpregnantwomen.blogspot.ie/2013/11/inquest-into-death-of-bimbo-onanuga.html