Cytotec[R] drug warning released from Searle. (News & Notes).Michael Cullen, MD, Medical Director of the Searle pharmaceutical company recently distributed a press release regarding the use of Cytotec[R] (misoprostol). What follows is an excerpt: Dear Health Care Practitioner: The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is indicated for the prevention of NSAID NSAID: see nonsteroidal anti-inflammatory drug. (nonsteroidal anti-inflammatory drugs Nonsteroidal Anti-Inflammatory Drugs Definition Nonsteroidal anti-inflammatory drugs are medicines that relieve pain, swelling, stiffness, and inflammation. )-induced gastric ulcers in patients at high risk of complications from gastric ulcer, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. The uterotonic effect of Cytotec is an inherent property of prostaglandin [E.sub.I] (PG [E.sub.1]), of which Cytotec is a stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy termination of pregnancy Induced abortion. See Abortion. , or for induction of labor Induction of Labor Definition Induction of labor involves using artificial means to assist the mother in delivering her baby. Purpose , in spite of the specific contraindications to its use during pregnancy. Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation per·fo·ra·tion n. 1. The act of perforating or the state of being perforated. 2. An abnormal opening in a hollow organ or viscus, as one made by rupture or injury. Perforation A hole. requiring uterine surgical repair, hysterectomy, or salpingo-oophorectomy; amniotic fluid embolism amniotic fluid embolism Obstetrics A condition resulting from a traumatic delivery and 'injection' of amniotic fluid containing lanugo, squames, mucus and debris into the opened maternal circulation, which communicates with the amniotic fluid Incidence 1:80,000 ; severe vaginal bleeding; retained placenta; shock; fetal bradycardia bradycardia: see arrhythmia. ; and pelvic pain. Searle had not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore, Searle is unable to provide complete risk information for Cytotec when it is used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, development, and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established. Searle promotes the use of Cytotec only for its approved indication. Further information may be obtained by calling 1-800-323-4204. |
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