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ACOG Committee Opinion: No. 283, May 2003. New U.S. Food and Drug Administration Labeling on Cytotec (Misoprostol) Use and Pregnancy
Publication year - 2003
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/s0020-7292(03)00248-0
Subject(s) - misoprostol , food and drug administration , medicine , citation , administration (probate law) , pregnancy , gynecology , family medicine , library science , abortion , law , pharmacology , political science , genetics , biology , computer science
On April 17, 2002, the U.S. Food and Drug Administration approved a new label for the use of Cytotec (misprostol) during pregnancy. The new labeling does not contain claims regarding the efficacy and/or safety of Cytotec when it is used for cervical ripening for the induction of labor nor does it stipulate doses or dosing intervals. Therefore, the Committee on Obstetric Practice reminds Fellows that this agent should be used as previously recommended.