Removes Contraindications and Warns of Harmful Side-Effects
WASHINGTON, April 19, 2002 (LSN.ca) – The US Food and Drug Administration yesterday released a labeling change notice to health care workers regarding Cytotec (misoprostol) – one of the drugs used in the RU-486 abortion regimen. Cytotec was originally used to treat ulcers and as such contained a strict labeling warning against use of the drug by pregnant women since it could cause abortion.
The FDA explained that the contraindication was removed since “The drug is widely used by obstetricians and gynecologists (OB-Gyns) to induce labor, delivery, and is part of the FDA approved regimen for use with mifepristone to induce abortion in pregnancies of 49 days or less.”
The FDA release also noted that the new labeling for the drug will provide “new information that uterine rupture, an adverse event reported with Cytotec, is associated with risk factors, such as later trimester pregnancies, higher doses of the drug, including the manufactured 100 mg tablets, prior Caesarean delivery or uterine surgery, and having had five or more previous pregnancies.”
See the FDA release on Cytotec: https://www.fda.gov/medwatch/SAFETY/2002/cytotec_changes.PDF