-VISIT OUR OTHER FORUMS- OB-GYN-L Ultrasound Ultrasound History Fibroid Forum Physicians-in-Training Tech Talk OBSTET-L (portuguese) OBGIN-L (spanish) Nursing

Re: The death of Cytotec/misoprostol as we know it From: Efrain Ramirez (eramirez@icepr.com) Fri Sep 15 17:30:51 2000 Messages sorted by: [ date ][ thread ][ subject ][ author ] Next message: Donna L. Elder: "Re: New HCFA Ruling" Previous message: maggiecnm: "Re: New HCFA Ruling" In reply to: Betsy Hyde: "Re: The death of Cytotec/misoprostol as we know it" Next in thread: Paul Prior MD: "Re: The death of Cytotec/misoprostol as we know it" Reply: Paul Prior MD: "Re: The death of Cytotec/misoprostol as we know it" Paul- would you want to see something like this -- hey everyone --this is me talking not ACOG Ok? IMPORTANT DRUG UPDATE CONCERNING THE USE OF INTRAVAGINAL OR ORAL MISOPROSTOL IN PREGNANT WOMEN FOR INDUCTION OF LABOR OR ABORTION Dear Doctor ___________: The purpose of this letter is to remind you that Cytotec administration by any route is not contraindicated in women who are pregnant when use in an appropriate fashion. Although Cytotec is not approved by the FDA for the induction of labor or abortion . Such "off-label" prescribing is legal and is not considered experimental if the use of the medication is based on sound, scientific studies. Cytotec is indicated for the prevention of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)-induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, 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 E1(PGE1), of which Cytotec is stable, orally active, synthetic analog making it one of the cheapest, most efficient and safest methods for cervical ripening and induction of labor ACOG has become aware that Searle has written a letter promoting its discontinuation as a method for cervical ripening. We consider that inappropriate and a disservice to the pregnant patient. Although serious adverse events reported following the use of Cytotec in pregnant, they are no different from other agents including oxytocin. Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle apparently intend to study or support these uses. The world literature has sufficient data to support its use so Searle can spare such studies. 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 different as with other agents. ACOG promotes the use of Cytotec only for its proven indications and with the appropriate methods. That would be a clear message -- IMHO - But as Art says "I could be wrong" At Fri, 15 Sep 2000, Betsy Hyde wrote: > >>>Anyone have the wording of the offending sentence(s) they can type here for >>>us to read? >>> >>>Joe P. >> >here is the letter from Searle re: cytotec. > >-- >Betsy Hyde CNM >Branford, CT > > New from G. D. Searle, manufacturer of Cytotec: > > August 23, 2000 > > Re:Cytotec(R) (misoprostol) > >IMPORTANT DRUG WARNING CONCERNING UNAPPROVED USE OF INTRAVAGINAL OR ORAL >MISOPROSTOL IN PREGNANT WOMEN FOR INDUCTION OF LABOR OR ABORTION > >Dear Health Care Provider: > >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 not approved for the induction of labor or abortion. > >Cytotec is indicated for the prevention of NSAID (nonsteroidal >anti-inflammatory drugs, including aspirin)-induced gastric ulcers in >patients at high risk of complications from gastric ulcer, e.g., the >elderly and patients with concomitant debilitating disease, 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 >E1(PGE1), of which Cytotec is 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, or for induction of labor, 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 requiring uterine surgical repair, hysterectomy or >salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, >retained placenta, shock, fetal bradycardia and pelvic pain. > >Searle has 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. > >Please read the enclosed updated complete Prescribing Information for Cytotec. >Further information may be obtained by calling 1-800-323-4204. > >Michael Cullen, MD >Medical Director, U.S. >Searle > -- "Do not take life too seriously. You will never get out of it alive." Marianne Williamson Next message: Donna L. Elder: "Re: New HCFA Ruling" Previous message: maggiecnm: "Re: New HCFA Ruling" In reply to: Betsy Hyde: "Re: The death of Cytotec/misoprostol as we know it" Next in thread: Paul Prior MD: "Re: The death of Cytotec/misoprostol as we know it" Reply: Paul Prior MD: "Re: The death of Cytotec/misoprostol as we know it"

Return to

Mail a New Message to the Forum: ob-gyn-l@obgyn.net Forum Administrator: geffrey.klein@obgyn.net Report Technical Problems: webmaster@obgyn.net Last Updated: Wed Jul 2 04:28:42 2008

The American Medical Association is no longer designating CME hours for AMA Category II CME credit. However, physicians themselves may self designate learning activities as Category II CME credit hours if they feel it is of sufficient educational merit and meets the formal definitions of continuing medical education. OBGYN.net believes these interaction in this forum meets these criteria. For further information see the AMA web site.