|
|
 |
 |
 |
|
|
|||
|
||||
|
||||
Re: Searle letterFrom: art fougner, md (evsono@pipeline.com)Sun Aug 27 22:15:14 2000
Dr. LSR - did you get this too? this reads as if the company lawyers dictated it. August 23, 2000 Re:Cytotec® (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 -------------------------------------------------------------------------------- Searle -------------------------------------------------------------------------------- 5200 Old Orchard Road -- -------------------------------------------------------------------------------- Skokie, Illinois, 60077 Phone: (847) 982-7000 Fax: (847) 470-1480
|
|
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 Dec 2 04:47:26 2009 |
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.