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Cytotec is a drug used to treat ulcers and is often used by doctors to induce labor. Cytotec has been associated with serious side effects, which include death, and is only approved as an ulcer medication.  Searle, the maker of Cytotec, states Cytotec  "is not approved for the induction of labor or abortion". Searle has never applied for FDA approval for Cytotec as a labor-inducing drug.

Despite the lack of FDA approval as a delivery drug, doctors have used cytotec to induce labor for several years. The use of a drug in a manner for which it has not received FDA approval is known as "off label" use and is permitted by the FDA. However, since Searle solely promotes cytotec as an ulcer prevention medication, and never intended the drug to be used as an inducement agent, no clinical trials were conducted to determine cytotec's safety when given to pregnant women. Instead, for several years obstetricians have used expectant women as guinea pigs, experimenting during labor in order to determine the ideal cytotec dose necessary to induce.

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. Cytotec should not be taken by pregnant women to reduce the risk of ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDS).  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