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- Cytotec in Obstetric ProceduresLast Updated: 7/21/2012
The FDA approves medications for prescription use when they become assured that the drug has been proven safe and effective. They review the company's application and the clinical trials for the specific use or indication planned for the pharmaceutical. At that point the FDA and the pharmaceutical company agree on specific language describing how the medication is to be administered and what should be placed on the drug package labeling. After this process, the physician is free to use the medication for the purpose it was designed and tested but they are also permitted to use it for any other purpose they would deem useful or effective. This process is called off-label use of medications. Off-label usage of medications may encompass anything from acne medication, cancer medication, anti-depressant medication, and antibiotic medication. Many pharmaceuticals are used off-label in the practice of obstetrics.
"Against Label" use of a medication is not the same thing as "Off Label" use.
According to Alexander Tabarrok in Assessing the FDA, Off Label Drug Prescribing, one study found that 23 percent of maternity patients had taken at least one drug for an off-label indication during their third trimester of pregnancy.
Misoprostol, marketed as Cytotec is one of those drugs. Cytotec was developed, tested, and approved for the treatment of stomach ulcers caused by NSAID use. It has an unstable uterotonic effect, many times causing hyperstimulation of the uterus. This effect is increased in a uterus that is previously scarred by a cesarean (with as much as a 5-28 % risk of uterine rupture), but has been known to happen in an un-scarred uterus as well. There is no way to know if someone is going to be overly sensitive to the drug's effects in a catastrophic manner or react mildly. The FDA has stated that the use of Cytotec for labor induction or for increased blood loss has NOT been approved. They go on to say as quoted here: "A major adverse effect of the obstetrical use of Cytotec is hyperstimulation of the uterus which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingooopherectomy), or AFE (amniotic fluid embolism). Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported."
Tatia Oden French is one woman who had a an AFE (Amniotic fluid embolism) released as a result of hyperstimulation of her uterus from the use of Cytotec. She was a healthy, young woman who was having her first child. Her labor was induced because she was a little shy of 42 weeks gestation. After the AFE occurred, an emergency cesarean was performed but both she and her unborn daughter died in the OR. Her mother tells her story both in the film The Business of Being Born, by director Ricki Lake, and HERE. Her organization, The Tatia Oden French Memorial Foundation, has petitioned the FDA for better regulation of Cytotec in obstetric cases, unfortunately without a favorable response.
Cytotec for abortion, labor induction or excessive postpartum bleeding is not approved nor appropriate at any time during pregnancy. That means not only is it OFF the label, it is AGAINST the label. Here is the image of the Cytotec label.
You can see the image of the pregnant woman with the line through it, clearly indicating it is not for use in pregnancy. The Manufacturer warnings state the use in pregnancy either for the induction of labor or abortion are both contraindicated. These are two of the most common uses during pregnancy. Another popular use is to stop a postpartum hemorrhage. There are no safety studies available for this process either. Are these women being given true informed consent regarding the risks, benefits and alternatives to these medications, I wonder? I have personally been present when several different women were NOT given true risks of the adverse effects that have happened and do happen regularly. When they asked the provider about the risks which they had discovered during research they were not verified, but in fact, downplayed.
You may be wondering WHY this medication is used with the serious risks associated with it, as I am. According to this article written Jan/Feb 2001: "The drug's appeal is twofold. Cytotec is much cheaper to use than other drugs: A dose costs less than 25 cents, compared with hundreds of dollars for other labor-inducing agents. It has also enabled doctors to induce more labors than ever before: Over the past decade, the induction rate has doubled -- 1 in 5 women now has her labor induced -- as doctors increasingly opt for additional medical intervention in childbirth. Speeding delivery can be medically necessary when the mother is overdue or at risk because of high blood pressure or diabetes, but critics charge that doctors often rely on Cytotec for "convenience inductions," using the drug to induce labor during office hours rather than letting nature take its course."
Eleven years has passed since this was written. (2012) How many mothers and babies have needlessly been put at risk?
Studies highlight real and catastrophic events associated with Cytotec. These are available on The Cochrane Collaboration. Numerous uterine ruptures and fetal distress episodes involving the drug are recorded. In spite of their recommendations ACOG issued guidelines in 1999 discouraging the use of Cytotec in women with prior cesareans, but yet insisting that the drug is safe at low doses. We do not need to test the effectiveness, that has been well-proven. What we DO need is the assurance of safety. That just isn't available.
Charles Lockwood, MD prior chairman of obstetrical practices for ACOG (American College of Obstetricians and Gynecologists) stated that Cytotec is now "the predominant agent of choice" for inducing labor, after a survey of 44 studies of the drug where Dr. Luis Sanchez-Ramos, professor of obstetrics and gynecology at the University of Fla concluded the women given Cytotec are more likely to have a vaginal delivery within 24 hours, and no more likely to require cesareans than women who receive no medication or another labor-inducing drug. He doesn't mention the risks associated with its use.
Searl, Cytotec's manufacturer, sent out a letter to over 200,000 health care providers warning them of the danger of this pharmaceutical product for these obstetrical procedures. Even they do not want their product used in this manner.
"Cytotec enables doctors to practice daylight obstetrics," says Dr. Marsden Wagner, a neonatologist who served for 15 years as a director of women and children's health in industrialized countries for the World Health Organization. "It means that as a doctor, I can come in at 9 a.m., give you the pill, and by 6 p.m. I've delivered a baby and am home having dinner."
The following organizations recommend the use of Cytotec in pregnancy:
Cytotec is used regularly in a multitude of hospitals around the USA for labor augmentations and inductions. Women would do well to educate themselves on the risks associated with it and inform their care provider if they do not want it used during their birth. Cytotec is a little pill that may be divided before dosage, but it cannot be withdrawn and there is no antidote. If you are using Cervidil for cervical ripening and encounter a problem, it can be removed. Pitocin can be turned off. Not so for Cytotec, once it is given, there is no turning back. Just because THEY say it's true, doesn't make it so. Nevermind them!! Decide for yourself!
To read personal events of adverse reactions or to report adverse events look here.
Other Cytotec sources:
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