Cytotec Labeling: Major Changes
Weitz and Luxenberg is no longer accepting Cytotec cases.
If you or a loved one has been harmed by off-label use of Cytotec, fill out this simple form today for a FREE case evaluation.
- Revises the contraindication and precaution that Cytotec should not be used
in women who are pregnant by stating that the contraindication is for pregnant
women who are using Cytotec to reduce the risk of non-steroidal
anti-inflammatory drug (NSAID)-induced stomach ulcers.
- Rationale: The drug has a recognized use 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 contraindication now refers to the drug’s approved indication, for reducing the risk of NSAID-induced gastric ulcers.
- Creates a new labor and delivery section of the labeling and provides safety information related to those uses. Rationale: 21 CFR 201.57(f)(7) requires labeling to include drug effect information if a drug has a recognized use during labor or delivery, whether or not the use is stated in the indications section of the labeling.
- Provides 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 mcg
tablets, prior Cesarean delivery or uterine surgery, and having had five or more
previous pregnancies.
- Rationale: Risk factors allow physicians to identify patients who may be at greater risk for these adverse events. This information may guide safer use of the drug.
5/21/02 www.FDA.gov
see also:
Breaking News
Cytotec Misoprostol Resources: Cytotec Breaking NewsCytotec Misoprostol Information: Cytotec (Misoprostol) Breaking News
Major Label Changes
FREE information about Cytotec Misoprostol - Major Label Changes from FDACytotec Major Label Changes: from the FDA
News & Warnings
Cytotec Lawsuits FREE Research Resourcesree information on Cytotec and Cytotec lawsuits.
