FDA makes major changes to Cytotec labeling. (Labor Assisting/Childbirth Education).Cytotec (misoprostol) is a synthetic prostaglandin used to reduce the risk of non-steroidal anti-inflammatory drug Non-steroidal anti-inflammatory drugs, usually abbreviated to NSAIDs, are drugs with analgesic, antipyretic and anti-inflammatory effects - they reduce pain, fever and inflammation. (NSAID NSAID: see nonsteroidal anti-inflammatory drug. )-induced stomach ulcers. Cytotec has been used since 1992 for abortions, as well as used "off-label" for induction of labor Induction of Labor Definition Induction of labor involves using artificial means to assist the mother in delivering her baby. Purpose , even though this use is considered controversial. In August of 2000, the manufacturer of Cytotec, G. D. Searle Corporation, issued a statement indicating that Cytotec is not approved for the induction of labor or abortion and that serious adverse effects had been reported following the off-label use of Cytotec in pregnant women. The adverse effects reported include uterine hyperstimulation, fetal distress, uterine rupture, hemorrhage, hysterectomy, 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 , and maternal and fetal death. On April 17, 2002 the Federal Drug Administration (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. ) made major changes to the labeling of Cytotec reversing the contraindication contraindication /con·tra·in·di·ca·tion/ (-in?di-ka´shun) any condition which renders a particular line of treatment improper or undesirable. con·tra·in·di·ca·tion n. in all pregnant women. The major changes to the labeling of Cytotec are listed below: * Removes the contraindication and precaution that Cytotec should not be used in women who are pregnant. * Clarifies that the contraindication is for pregnant women who are using Cytotec to reduce the risk on non-steroidal anti-inflammatory drug (NSAID)-induced stomach ulcers. * Creates a new labor and delivery section of the labeling and provides safety information related to those uses. * Provides new information that uterine rupture, an adverse event reported with Cytotec, is associated with risk factors such as later trimester trimester /tri·mes·ter/ (-mes´ter) a period of three months. tri·mes·ter n. A period of three months. Trimester The first third or 13 weeks of pregnancy. pregnancies, higher doses of the drug, including the manufactured 100mcg tablets, prior cesarean delivery or uterine surgery, and having had five or more previous pregnancies. Removing the contraindication for use by pregnant women from the labeling may make some providers feel safer using Cytotec to induce labor, so more of your clients may be facing choices regarding the use of Cytotec. The following is a list of references for you and your clients to learn more about Cytotec and its possible effects during labor. References ACOG ACOG American College of Obstetricians and Gynecologists. ACOG American College of Obstetricians & Gynecologists . 1999. Induction of labor with misoprostol. Committee Opinion 128. Gaskin gaskin the muscular portion of the hindleg between the stifle and hock, corresponding to the human calf. The term is used in horses and sometimes dogs. I. M. 2000. Two sides to the Cytotec debate. Birth Gazette, Nov. 16 (2): 7, 48-49. Hofmeyr G. J., A. M. Gulmezoglu, and Z. Alfirevic. 1999. Misoprostol for induction of labour: A systematic review. Br. J. Obstet. Gynaecol. 106: 798-803. Reuters Health. Aug 29, 2000. Off-label Cytotec use for labor, abortion prompts Searle letter to physicians. Sanchez-Ramos, L., et al. 1997. Misoprostol for cervical ripening and labor induction: A meta-analysis. Am. J. Obstet. Gynecol. 89: 4, 633-642. Wagner, M. 1999. Misoprostol (Cytotec) for labor induction: A cautionary tale. Midwifery Today Spring (49): 31-33. Relevant Websites http://www.childbirth.org/articles/cytotec.html http://www.parentsplace.com/print/0,11648,187894,00. html http:/www.motherjones.com/mother_jones/JF01/labor.html http://www.midwiferytoday.com/articles/default.asp?t= misoprostol http://salon.com/health/feature/2000/07/11/cytotec/index. html http://www.urbanview.com/04.03.02/pill-0214.html |
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