Abortion, Premature Birth, Birth Defects
- Abortion, premature birth and birth defects have been reported with misoprostol administration to pregnant women.
Labor and Delivery
- Use of misoprostol for the management of postpartum hemorrhage has been associated with reports of high fevers (greater than 40 degrees Celsius or 104 degrees Fahrenheit), accompanied by autonomic and central nervous system effect, such as tachycardia, disorientation, agitation, and convulsions. These fevers were transient in nature. Supportive therapy should be dictated by the patient's clinical presentation
- Uterine rupture has been reported when misoprostol was administered to pregnant women to induce labor or abortion beyond 8th week of pregnancy
- Should not be taken by pregnant women for risk reduction of NSAID ulcers
- Patients must be advised of the abortifacient properties of this agent and warned not to give the drug to others.
- Misoprostol should not be used for reducing the risk of NSAID induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with the use of NSAID, or is at high risk of developing gastric ulceration.
- Requirements: In such patients, misoprostol may be prescribed if the patient 1) has had a negative serum pregnancy test within 2 weeks prior to beginning therapy. 2) is capable of complying with effective contraceptive measures. 3) has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake. 4) will begin therapy with misoprostol only on the second or third day of the next normal menstrual period.
FDA and Industry Communications
Updated June 2018