Misoprostol (Cytotec)
Science & Sensibility
From Lamaze International
August 17th, 2009 by Henci Goer
Summary:
"In other words, Cytotec’s real benefits are convenience for obstetricians and helping the hospital’s bottom line. For women and babies, though, it’s a roll of the dice. Most times things go fine, but sometimes the dice come up snake eyes."
From the FDA 2002 Statement:
A major adverse effect of the obstetrical use of Cytotec is hyperstimulation of the uterus which may progress to uterine tetany [uterus contracts and doesn't let go] with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy [removal of the ovaries and Fallopian tubes]), or amniotic fluid embolism [maternal and infant mortality is very high from this]. Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia [profound slowing of the fetal heart], and fetal and maternal death have been reported.
There may be an increased risk of uterine tachysystole [contractions coming too fast], uterine rupture, meconium passage, meconium staining of amniotic fluid, and Cesarean delivery due to uterine hyperstimulation with the use of higher doses of Cytotec; including the manufactured 100 mcg tablet. The risk of uterine rupture increases with advancing gestational ages and with prior uterine surgery, including Cesarean delivery. Grand multiparity [usually defined as more than four births] also appears to be a risk factor for uterine rupture.
Cytotec's manufacturer, G. D. Searle Corporation authored the following warnings:
WARNINGS
CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY (see also PRECAUTIONS, and LABOR AND DELIVERY). CYTOTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS.
Cytotec should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing
potential unless the patient is at high risk of complications from gastric ulcers associated with use of the
NSAID, or is at high risk of developing gastric ulceration. In such patients, Cytotec may be prescribed if
the patient
• has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
• is capable of complying with effective contraceptive measures.
• has received both oral and written warnings of the hazards of misoprostol, the risk of possible
contraception failure, and the danger to other women of childbearing potential should the drug be
taken by mistake.
• will begin Cytotec only on the second or third day of the next normal menstrual period.
(Exerpts:)
Information for patients: Women of childbearing potential using Cytotec to decrease the risk of
NSAID induced ulcers should be told that they must not be pregnant when Cytotec therapy is initiated,
and they must use an effective contraception method while taking Cytotec.
SPECIAL NOTE FOR WOMEN: Cytotec may cause abortion (sometimes incomplete), premature
labor, or birth defects if given to pregnant women.
Pregnancy: Pregnancy Category X.
Teratogenic effects: See boxed WARNINGS. Congenital anomalies sometimes associated with fetal
death have been reported subsequent to the unsuccessful use of misoprostol as an abortifacient but the
drug’s teratogenic mechanism has not been demonstrated. Several reports in the literature associate the use of misoprostol during the first trimester of pregnancy with skull defects, cranial nerve palsies, facial malformations, and limb defects.
Cytotec in not fetotoxic or teratogenic in rats and rabbits at doses 625 and 63 times the human dose,
respectively. Nonteratogenic effects: See boxed WARNINGS. Cytotec may endanger pregnancy (may cause abortion) and thereby cause harm to the fetus when administered to a pregnant woman. Cytotec may produce uterine contractions, uterine bleeding, and expulsion of the products of conception. Abortions caused by Cytotec may be incomplete. If a woman is or becomes pregnant while taking this drug to reduce the risk of NSAID induced ulcers, the drug should be discontinued and the patient apprised of the potential hazard to the fetus.
Labor and Delivery:
Cytotec can induce or augment uterine contractions. Vaginal administration of Cytotec, outside of its
approved indication, has been used as a cervical ripening agent, for the induction of labor and for
treatment of serious postpartum hemorrhage in the presence of uterine atony. A major adverse effect of
the obstetrical use of Cytotec is hyperstimulation of the uterus which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism. Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported.
There may be an increased risk of uterine tachysystole, uterine rupture, meconium passage, meconium
staining of amniotic fluid, and Cesarean delivery due to uterine hyperstimulation with the use of higher
doses of Cytotec; including the manufactured 100 mcg tablet. The risk of uterine rupture increases with
advancing gestational ages and with prior uterine surgery, including Cesarean delivery. Grand multiparity also appears to be a risk factor for uterine rupture.
