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Re: - Letter From: Richard Chudacoff, MD (rchudacoff@mylinuxisp.com) Fri Sep 15 09:45:30 2000 Messages sorted by: [ date ][ thread ][ subject ][ author ] Next message: Luis Sanchez-Ramos, MD: "Re: The death of Cytotec/misoprostol as we know it" Previous message: art fougner, md: "Re: Bacterial vaginosis" In reply to: james connerth: "- Letter" Next in thread: art fougner, md: "Re: - Letter" Reply: art fougner, md: "Re: - Letter" I still think the literature supports its use in induction for fetal demise, term pregnancies and therapeutic ABs. Rick -- Richard Chudacoff, MD Chudacoff Obstetrics & Gynecology, PLLC 15200 Southwest Freeway, #270 Sugar Land, TX 77478 Tel: 281-277-3900 Fax: 281-277-3901 rchudacoff@mylinuxisp.com <mailto:rchudacoff@mylinuxisp.com> Richard.Chudacoff@obgyn.net ********************************************************************** Neither the confidentiality nor the integrity of this message can be guaranteed following transmission on the Internet. ********************************************************************** -----Original Message----- From: ob-gyn-l@obgyn.net [mailto:ob-gyn-l@obgyn.net]On Behalf Of james connerth Sent: Friday, September 15, 2000 8:56 AM To: Multiple recipients of list OB-GYN-L Subject: - Letter [U.S. Food and Drug Administration] _____ FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company. _____ This is the retyped text of a letter from Searle. Contact the company for a copy of any referenced enclosures. _____ August 23, 2000 Re:Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > . (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 < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > administration by any route is contraindicated in women who are pregnant because it can cause abortion. < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > is not approved for the induction of labor or abortion. < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > 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 < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > is an inherent property of prostaglandin E1(PGE1), of which < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > is stable, orally active, synthetic analog. Searle has become aware of some instances where < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > , 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 < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > 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 < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > 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 < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > when it is used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > on the later growth, development and functional maturation of the child when < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > is used for induction of labor or cervical ripening has not been established. Searle promotes the use of < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec > <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > only for its approved indication. Please read the enclosed updated complete Prescribing Information for < <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=htt p%3A%2F%2Fwww%2Efda%2Egov%2Fmedwatch%2Fsafety%2F2000%2Fcytote%2Ehtm&DocOffse t=1&DocsFound5&QueryZip=cytotec&Collection=all&SearchUrl=http%3A%2F%2Fwww% 2Everity%2Efda%2E > Cytotec. Further information may be obtained by calling 1-800-323-4204. Michael Cullen, MD Medical Director, U.S. Searle _____ Searle 5200 Old Orchard Road Skokie, Illinois, 60077 Phone: (847) 982-7000 Fax: (847) 470-1480 _____ Return to Summary <http://www.fda.gov/> _____ Return to MedWatch Home Page <http://www.fda.g> Your Comments Please <http://www.fda.gov> Return to Safety Issues Page <http://www.fda.g> [FDA Home Page] <http://www.fda.gov/fdahom> Next message: Luis Sanchez-Ramos, MD: "Re: The death of Cytotec/misoprostol as we know it" Previous message: art fougner, md: "Re: Bacterial vaginosis" In reply to: james connerth: "- Letter" Next in thread: art fougner, md: "Re: - Letter" Reply: art fougner, md: "Re: - Letter"

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