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Kaiser Daily Women's Health Policy
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National Politics & Policy | New Misoprostol Label Revises Contraindication for Pregnant Women, Recognizes Drug's Use in Labor
[Apr 19, 2002]

     The FDA said yesterday that it has changed the label of the drug Cytotec to reflect the fact that it is widely used by doctors to induce labor and is also part of the FDA-approved regimen for inducing medical abortion, Reuters Health reports. The label for Cytotec, which is known generically as misoprostol and was originally approved to treat ulcers, had stated that pregnant women should not take the drug under any circumstances, a warning that the FDA has now removed. The change reflects the frequent off-label use of the drug by obstetricians and gynecologists to induce labor and delivery. In addition, Cytotec, which is made by Pharmacia, is prescribed in combination with the drug mifepristone (RU-486) to induce abortions early in pregnancy. The new label will keep the warning that women who are taking Cytotec to treat ulcers should not become pregnant (Reuters Health, 4/18). An FDA summary of the label changes is available online. In addition, the new label itself may be viewed online. Note: You will need Adobe Acrobat Reader to view the documents.

For current women's health policy news, visit the National Partnership for Women & Families' website.


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