Gynecological and Obstetrical Uses of Misoprostol

Off-label use of medication is common enough that we have a well known catch phrase to describe it. Unexpected properties of an adhesive resulted in the creation of 3M's Scotchgard. Side effects of a chest medication have made Viagra such a household name that we all know about this "little blue pill," even if we have no call to use it ourselves. Similarly, off-label use in gynecological and obstetrical settings of an ulcer medication called misoprostol has brought it into the public eye as well. Misoprostol is controversial because of its use in medical abortion, but it has a number of other well documented uses in women's reproductive health as well. Because the patent holders have not applied for approval for these uses, they continue to be off-label despite a growing body of evidence that the drug is effective and safe in these instances.

Ulcer medication used off-label for medical abortion

Misoprostol is a drug used to prevent and treat gastric ulcers in people who regularly take non-steroidal anti-inflammatory drugs (NSAIDs.) It was originally marketed by the pharmaceutical company Searle (now part of Pfizer) in 1985, and today is available in over 85 countries worldwide. Misoprostol, sold in the United States under the brand name Cytotec, is also used in women's reproductive health in a large number of countries. Its use in medical abortions, either alone or in combination with other drugs, is one of its best known and most controversial off-label uses. The controversy surrounding the drug may be one reason the pharmaceutical company has never sought licensing for use in women's health settings, however educating law makers and the public about its other uses could remedy that situation.

Properties of misoprostol exploited for off-label use in women's reproductive health

Misoprostol is a synthetic prostaglandin, a hormone-like substance. Prostaglandins have a number of important functions in the human body, including the dilation of breathing passages and blood vessels. They can also help to contract or relax certain muscles, the muscles of the uterus among them. Misoprostol was originally approved for its ability to decrease gastric secretions, but when it is used in women's health care the properties of most interest are its ability to cause uterine contractions and cause ripening or dilation of the cervix.

In addition to inducing medical abortions, misoprostol has also been used to induce term labour and to prevent or treat postpartum bleeding. In cases of incomplete miscarriage, the drug is used as a safer medical alternative to surgical treatment by dilation and curettage (D&C.) It is also possible to use misoprostol to ripen the cervix prior to exploratory gynecological procedures or insertion of an intrauterine contraceptive device (IUD.) For women who have previously had a caesarian section, misoprostol can be used to induce labour, allowing for a vaginal birth (VBAC.)

Although Cytotec has never been approved for anything other than treatment of ulcers, patents in some regions have expired and misoprostol is now available as a generic or brand name medication for gynecological and obstetrical use. Although the use is not yet government approved in North America, OB/GYN use is approved in a number of Asian, European, South American and African nations. Off-label use of misoprostol in women's reproductive health is common in both th United States and Canada.

World Health Organization adds misoprostol to essential medicines list

Because misoprostol is inexpensive and does not require special storage conditions, the drug has been favoured in developing countries. Off-label use of misoprostol in gynecology and obstetrics is considered safe and is backed up by medical research. In 2005 the World Health Organization added misoprostol to its list of essential medications to serve high priority health needs in these countries. WHO statistics indicate that close to 20 million women each year have unsafe abortions - abortions performed by untrained individuals or in unhygienic conditions. Almost all of the world's unsafe abortions happen in developing countries, many of which have restrictive laws that forbid safe abortions. The number of women who die each year from unsafe abortions could be as high as 68,000.

Sources:

Marge Berer, "Medical abortion: A fact sheet." Reproductive Health Matters

D. O. E. Gebhardt, "Misoprostol in a topsyturvy world." Journal of Medical Ethics

Misoprostol in Gynaecology and Obstetrics advocacy web site

Unsafe abortion: Global and regional estimates of the incidence of unsafe abortion and associated mortality in 2003. World Health Organization

"WHO adds mifepristone and misoprostol to essential medicines list." Reproductive Health Matters