Approved by the FDA for the prevention of gastric ulcers in high-risk patients (such as elderly people taking a nonsteroidal anti-inflammatory drug like ibuprofin), Cytotec has been used off-label to induce labor or abortion in pregnant women. Cytotec's manufacturer, Searle & Co., Inc., never intended such a use for the drug and has tried to warn physicians about the potential dangers associated with using Cytotec with pregnant women.
Cytotec has been linked to cases of infant and maternal death when used to induce labor. It has also caused uterine rupture, which may require a hysterectomy (removal of the uterus, making future pregnancy impossible). Bleeding and pain may also occur. In 2000, Searle and the FDA issued a warning letter to doctors, reminding them that Cytotec is contraindicated for pregnant women and that it is not intended to be used as a means to induce labor.
Despite their earlier warnings to doctors and the known dangers of Cytotec, the FDA reversed course in 2002. Searle and the FDA decided to allow doctors to use the drug for labor induction and approved its use in conjunction with mifepristone for medical abortion.
If you, or someone you know, have been injured by taking Cytotec while pregnant, you may be able to file a lawsuit. Please contact us to learn more.