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Cytotec Information


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December 12th, 2006, 01:28 PM
wonderfullymade's Avatar Doula & MW Apprentice
Join Date: Jan 2006
Location: Galveston, TX
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The FDA has a new page on Cytotec. The warning about risk remains the same and the Patient Information Sheet still says in reference to uses in pregnancy, labor, deliver or after delivery:

"These uses are not approved by the FDA."

Go to http://www.fda.gov/cder/drug/infopage/miso...tol/default.htm

for further information.

FDA ALERT Risks of Use in Labor and Delivery

This Patient Information Sheet is for pregnant women who may receive misoprostol to soften their cervix or induce contractions to begin labor. Misoprostol is sometimes used to decrease blood loss after delivery of a baby. These uses are not approved by the FDA. No company has sent the FDA scientific proof that misoprostol is safe and effective for these uses.

There can be serious side effects, including a torn uterus (womb), when misoprostol is used for labor and delivery. A torn uterus may result in severe bleeding, having the uterus removed (hysterectomy), and death of the mother or baby. These side effects are more likely in women who have had previous uterine surgery, a previous Cesarean delivery (C-section), or several previous births.

This information reflects FDAs preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available.
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