FDA alert regarding Cytotec.In November of 2004, the Tatia Oden French Memorial Foundation presented a petition to the Food and Drug Administration, demanding a more complete review of the hazards of Cytotec (Misoprostol), especially in regard to labor induction and cervical ripening cervical ripening Obstetrics The stromal response of the cervix in phase 1 of parturition, which precedes the onset of labor, in which the cervix becomes softer and more dilatable. See Cervical effacement. . By September, 2005 over 2,210 signatures had been received for the petition. On May 16, 2005, the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. issued an alert on the risks of Cytotec (Misoprostol) which states: "This Patient Information Sheet is for pregnant women who may receive Misoprostol to soften their cervix or induce contractions to begin labor. Misoprostol is sometimes used to decrease blood loss after delivery of a baby. The FDA does not approve these uses. No company has sent the FDA scientific proof that Misoprostol is safe and effective for these uses. There can be rare but serious side effects Side effects Effects of a proposed project on other parts of the firm. , including a torn uterus (womb), when Misoprostol is used for labor and delivery. A tom uterus may result in severe bleeding, having the uterus removed (hysterectomy hysterectomy (hĭstərĕk`təmē), surgical removal of the uterus. A hysterectomy may involve removal of the uterus only or additional removal of the cervix (base of the uterus), fallopian tubes (salpingectomy), and ovaries ), and death of the mother or baby. These side effects are more likely in women who have had previous uterine uterine /uter·ine/ (u´ter-in) pertaining to the uterus. u·ter·ine adj. Of, relating to, or in the region of the uterus. surgery, a previous Cesarean cesarean /ce·sar·e·an/ (se-zar´e-an) see under section. ce·sar·e·an or cae·sar·e·an or cae·sar·i·an or ce·sar·i·an adj. Of or relating to a cesarean section. delivery (C-section), or several previous births." This FDA Alert makes it clear that * the use of Cvtotec for labor induction is not approved * there is not enough scientific evidence to support the use of Cytotec for this practice. * the side effects of Cytotec (Misoprostol) include serious injury and even death. Every woman discussing induction with her provider should be aware and fully informed about the dangers of Cytotec. Educators, doulas, doctors, midwives, nurses and other health care providers also need to be fully informed of these serious consequences. The official alert and the patient information sheet can be found on the EDA (1) (Electronic Design Automation) Using the computer to design, lay out, verify and simulate the performance of electronic circuits on a chip or printed circuit board. website: www. fda.gov/drug/infopage/misoprostol. The Tatia Oden French Memorial Foundation was established in honor of Tatia Oden French, who died from complications in childbirth due to the use of Cytotec. Their purpose is to "to empower women around the issues of childbirth and pregnancy. (Their) main focus is on maternal mortality, the off label use of drugs and informed consent". Their web site is www.tatia.org |
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