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 supports all maternity service users to navigate the system as it exists, and campaigns for a system which truly meets the needs of all. AIMS does not give medical advice, but instead we focus on helping women to find the information that they need to make informed decisions about what is right for them, and support them to have their decisions respected by their health care providers. The AIMS Helpline volunteers will be happy to provide further information and support. Please email firstname.lastname@example.org or ring 0300 365 0663.
AIMS Journal, 2020, Vol 32, No 4 Lorna Tinsley Interview by Rachel Boldero AIMS believes that an effective Nursing and Midwifery Council (NMC) is crucial for a well-funct…Read more
AIMS Journal, 2020, Vol 32, No 4 By Wendy Jones PhD MRPharmS MBE ‘ Scientific, evidence-led information which is very up to date and relevant, and … better informed than…Read more
AIMS Journal, 2020, Vol 32, No 4 The OBS facilitators: Charlotte Gilman, Julie Gallegos, Lisa Mansour and Jayne Joyce (left to right) By Jayne Joyce IBCLC Project Lead Ox…Read more
POSTPONED FROM JUNE 2020 Making a difference past and future The purpose of the day is to celebrate what Birth Activists in general and AIMS in particular have achieved,…Read more
AIMS has submitted comments on the draft update of the NICE Neonatal Infection Guideline. You can read our comments here . The details of the draft guidelines can be foun…Read more
In many parts of the country, there is now momentum building in favour of the implementation of a relational model of maternity care. This is something that AIMS has been…Read more
AIMS has submitted comments on the draft update of the NICE Caesarean Section Guideline You can read our comments here The details of the draft and update schedule can be…Read more