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Cytotec, made by Searle (now part of Pfizer), was approved in March 1999 by the U.S. Food and Drug Administration (FDA) for the prevention of gastric ulcers induced by non-steroidal anti-inflammatory drugs (NSAID). It is also used off-label, however, to induce labor and to end pregnancies prematurely.
Cytotec works by stimulating increased secretion of the mucus that lines the gastrointestinal tract and increasing mucosal blood flow. The lining of mucus helps protect against the gastric ulceration that results as a common side effect of NSAIDs. Misoprostol also promotes uterine contractions and cervical ripening (softening of the cervix and undertaking of chemical changes which allow it to dilate for the delivery of a fetus).
Its relatively low cost makes it appealing to induce labor. But in August 2000, Searle sent an open letter to physicians reminding them that Cytotec is not approved by the FDA for this purpose. And then in May 2005, the FDA itself issued an alert warning that there were serious potential side effects when misoprostol was used to induce labor or to decrease blood loss after the delivery of a baby.
One of the side effects the FDA alert identifies is a torn uterus (or womb), which can lead to severe bleeding, a hysterectomy (removal of the uterus), and/or death of the mother or baby. It also points out that the side effects are more likely in women who had multiple previous births, a previous C-section (Cesarean delivery), or previous uterine surgery.
Other risks of using the drug to induce labor include hyperstimulation syndrome, tachysystole, and hypersystole, all of which are abnormal and potentially dangerous labor contractions.
Even when used in treatments for which Cytotec is approved, common side effects include:
- Abdominal pain
- Flatulence (excess gas)
- Dyspepsia (heartburn)
If you or a loved one has suffered or is suffering from side effects after taking Cytotec, you may be entitled to compensation. To find out, you may wish to consult with a qualified pharmaceutical injury attorney.