CYTOTEC WARNINGS

   
     

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Following are direct excerpts from the FDA mandated changes to the package insert in each package of Cytotec. 

From : http://www.fda.gov/cder/foi/label/2002/19268slr037.pdf

Cytotec®

(misoprostol)

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 i 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.

. . .

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.

The effect of Cytotec on the later growth, development, and functional maturation of the child when Cytotec is used for cervical ripening or induction of labor have not been established. Information on Cytotec's effect on the need for forceps delivery or other intervention is unknown.

. . .

PATIENT INFORMATION

Read this leaflet before taking Cytotec® (misoprostol) and each time your prescription is renewed, because the leaflet may be changed.

Cytotec (misoprostol) is being prescribed by your doctor to decrease the chance of getting stomach ulcers related to arthritis/pain medication that you take.

Do not take Cytotec to reduce the risk of NSAID induced ulcers if you are pregnant ( See boxed WARNINGS).  Cytotec can cause abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. It is also important to avoid pregnancy while taking this medication and for at least one month or through one menstrual cycle after you stop taking it.  Cytotec has been reported to cause the uterus to rupture (tear) when given after the eighth week of pregnancy.  Rupture (tearing) of the uterus can result in severe bleeding, hysterectomy, and/or maternal or fetal death.

If you become pregnant during Cytotec therapy, stop taking Cytotec and contact your physician immediately.  Remember that even if you are on means of birth control it is still possible to become pregnant. Should this occur, stop taking Cytotec and contact your physician immediately.

from:

G.D. Searle & Co.

Box 5110, Chicago IL 60680

Address medical inquiries to:

G.D. Searle & Co.

Healthcare Information Services

5200 Old Orchard Road

Skokie, IL 60077


 

Click on the following link to review the package insert in its entirety:

From : http://www.fda.gov/cder/foi/label/2002/19268slr037.pdf

 


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