IMPORTANT DRUG WARNING CONCERNING UNAPPROVED USE OF INTRAVAGINAL OR ORAL MISOPROSTOL IN PREGNANT WOMEN FOR INDUCTION OR LABOR OR ABORTION
August 23, 2000
Re: Cytotec (misoprostol)
Dear Health Care Practitioner:
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, eg 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 a 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 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 Cytotecon 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, US
AIMS Journal, 2019, Vol 31, No 3 By Emma Ashworth For years, AIMS produced a small book called “Making a Complaint about Maternity Care” which looked at the different way…Read more
AIMS Journal, 2019, Vol 31, No 3 By Shane Ridley I’m very pleased to introduce a book, The AIMS Guide to Resolution After Birth , which is being released shortly, in the…Read more
AIMS Journal, 2019, Vol 31, No 3 By Beth Whitehead After a difficult birth, it is natural to feel overwhelmed and exhausted. What I found the toughest part to deal with w…Read more
The festival runs from 8am to 5pm on 23rd April 2020 and includes expert speakers, an exhibition, seminars and an awards ceremony. Speakers include: Mary Renfrew FRSE (Pr…Read more
8.30am - 5pm Study day, including networking breaks and lunch, with sessions on the following topics: Bipolar support in pregnancy and planning for the postnatal period M…Read more
Details TBCRead more
Sent 9th May 2019 By email ( email@example.com ) Dear Sir, I write in response to the opinion piece by Barbara Ellen entitled “Meghan Markle’s home birth s…Read more
Download PDF MBRRACE-UK: Saving Lives, Improving Mothers’ Care MBRRACE-UK: Perinatal Mortality Surveillance report for births in 2016 www.npeu.ox.ac.uk/mbrrace-uk/reports…Read more
Download PDF Commissioners and providers across England, guided by their MVPs, are working across the country to implement sustainable Continuity of Carer models of care,…Read more