Misoprostol (Cytotec)

ISSN 0256-5004 (Print)

AIMS Journal Vol 13 No 3

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
Searle

Latest Content

Journal

« »

Editorial: Mission Better Births. B…

AIMS Journal, 2018, Vol 30, No1 By Jo Dagustun, Editor I’m going to start with an assumption: that everyone reading this Journal is already convinced that we can do far b…

Read more

The Consequences of Discontinuing C…

AIMS Journal, 2018, Vol 30, No1 A birth story by Emma Ashworth It was my booking-in appointment for my second baby, and I didn’t want to be there. I didn’t want to birth…

Read more

Campaign update: Is the NMC fit for…

AIMS Journal, 2018, Vol 30, No1 By the AIMS Campaign Team Change at the NMC: why is this important to AIMS? AIMS recognises that a large number of taxpayer funded nationa…

Read more

Events

« »

Improving Patient Safety & Care

http://ipc2019.govconnect.org.uk/index.php?option=com_content&alias=our-mission-early-years-profiles-2018&view=article&id=73&Itemid=181

Read more

4th Annual Birth Trauma Event

Details on Eventbrite Organised by Dr Rebecca Moore who has recently founded to the Make Birth Better Network

Read more

MBRRACE-UK ‘Saving Lives, Improving…

To register your interest please email conference@npeu.ox.ac.uk or keep an eye on our website https://www.npeu.ox.ac.uk/mbrrace-uk/bookings . Earlybird bookings will open…

Read more

Latest Campaigns

« »

Ágnes Geréb is granted clemency by…

28 th June 2018 "This act of clemency is about more than me. It is an acknowledgement of liberty in giving birth. It is a recognition by the state that the rights of wome…

Read more

Press Release: Jeremy Hunt announce…

AIMS is delighted that the Government has recognised the importance to the safety of women and babies of the continuity of carer model of midwifery. Having a midwife that…

Read more

Dr. Ágnes Geréb, Hungarian Midwife…

Dr. Ágnes Geréb is a Hungarian obstetrician and midwife who has been fighting for her freedom following her house arrest and thret of imprisonment due to her support for…

Read more