Same prostaglandin used in RU 486/PG abortions

Congenital Malformations
Associated With Misoprostol

By Randall K. O'Bannon, Ph.D.

An article appearing in the May 30, 1998, issue of the international medical journal The Lancet 1 describes a pattern of congenital malformations associated with use of the prostaglandin misoprostol in babies who have survived abortions in which misoprostol was used alone. Properly used, misoprostol is an effective anti-ucler drug.

Typically, misoprostol (commonly used under the name Cytotec) is the prostaglandin (PG) used in the second stage of RU 486/PG abortions. It is administered to stimulate powerful uterine contractions to expel the baby who has already been starved or suffocated by RU 486 pills typically taken by the mother two days earlier.

When it is not used in combination with RU 486, misoprostol can induce an abortion, but much less "effectively." That means that women can give birth after misoprostol "fails."

The seven authors of the Lancet article studied the teratogenic properties (i.e., having the effect of inducing embryonic maldevelopment) of the drug in Brazil, where misoprostol, used alone, has often been employed (illegally and improperly) as an abortifacient. The label for misoprostol states that it should not be used by pregnant women because it causes uterine contractions. The manufacturer, Searle, has stated that it does not wish its product to be used for abortion.

Earlier studies have reported on certain cases of developmental abnormalities in babies who survived the chemical abortion attempt thought to be attributable to misoprostol.2 The Lancet study is perhaps the first to attempt to systematically identify and categorize the particular malformations as well as the systems affected when this prostaglandin is used to abort.

Between May 1992 and April 1997, the authors studied 42 misoprostol-exposed infants who were referred to a university hospital in São Paulo, Brazil. The most common developmental anomalies observed were equinovarus (clubfoot) in 27-30 of the children (the chart and text are unclear); cranial nerve defects in 21 of the children, resulting in partial paralysis of certain facial muscles and affecting eye control; and in 10 children arthogryposis, a condition in which certain muscles (in these cases, the legs and/or arms) are in a persistent state of flex or contraction similar to the spasms experienced in lockjaw or muscle cramps.

Other anomalies were found in the children who survived the attempted abortion: 13 children were born with fused, webbed, shortened, or missing fingers and/or toes; eight children experienced hydrocephalus, sometimes referred to as "water on the brain"; and five children were born with microcephaly, an abnormal smallness of the head. In addition, the bones or muscles of some children failed to completely develop.

Dr. Claudette Gonzalez and the other doctors who authored the study speculate that these abnormalities are consistent with those attributed to "vascular disruption," or a disruption of blood flow in the developing fetus. All women participating in the study admitted to having taken misoprostol during the first trimester of pregnancy, precisely at the time when crucial organs, systems, and body parts of the unborn child are developing.

According to one theory mentioned in the article, the uterine contractions triggered by misoprostol may lead to a bending of the fetus at the level of the sixth and seventh cranial nerves, causing a decrease in blood flow to developing muscles, bones, skin, and nerves. Gonzalez and the other authors believe the contractions may also disrupt blood flow to the brain stem at this crucial time.

When it became widely known that many women in Brazil were using misoprostol to attempt to abort, restrictions were put on its use. While there was an 80% decrease in sales of the drug, misoprostol can still be purchased from pharmacies or bought on the black market. This prompted the authors to write, " Information on the effects of taking misoprostol during pregnancy should be made more widely available, to dissuade women from misusing the drug."

Dr. Gonzalez, the lead author of the study, told the Reuters news agency (5/29/98), "We hope that greater awareness of the widespread use of misoprostol to induce abortions will lead to new public-health measures to prevent these tragic consequences."

Those who promote and intend to sell RU 486 in the U.S. do not deny that misoprostol may cause serious developmental impairments in children who survive an attempted RU 486/PG abortion. In a recent article that appeared in the April 30, 1998, edition of New England Journal of Medicine 3 (reviewed in NRL News, 5/7/98), the RU 486 researchers who wrote the story say point blank that "Careful medical follow up is essential to ensure that surgical abortion is performed in cases of failed medical abortion."

Why? The authors trivialize the dangers associated with RU 486, suggesting that the only malformations found were in the skulls of rabbits. By contrast, "Misoprostol...has been reported to be teratogenic in humans."

To the abortion researchers of the Population Council, conductors of the U.S. trial, however, this is not a reason to abandon the drug as part of the RU 486/PG abortifacient tandem, but a reason to compel women for whom the drugs are not successful to have surgical abortions. This is why each woman who participated in the U.S. trials of RU 486 in 1994-95 was asked to sign an informed consent document stating that she understood this risk and would agree to undergo a surgical abortion if the drugs failed.

Yet over a hundred women from the U.S. trial were "lost" between the second and third stages of the RU 486/PG protocol. Some of these women were known, or suspected to be, still pregnant. The abortion researchers writing the New England Journal of Medicine article conceded that the ultimate outcome of these pregnancies is unknown, "despite our repeated attempts to contact the women."

These problems came even though the American tests were under the carefully controlled and monitored conditions of a clinical trial. How many more women will be "lost" to follow up once the standards and protocols are loosened and laxly enforced? While the exact number is unknowable, it is quite likely that a number of children will be born with the serious sorts of disabilities mentioned here.

FOOTNOTES

1.) C.H. Gonzalez, M.D., M.J. Marques-Dias, C.A. Kim, M.D., S.M.M. Sugayama, M.D., J.A. Da Paz, M.D., S.M. Huson, M.D., L. B. Holmes, M.D., "Congenital abnormalities in Brazilian children associated with misoprostol misuse in first trimester of pregnancy," The Lancet, Vol. 351, No. 9116 (May 30, 1998), pp. 1624-1627.

2.) W. Fonseca, A.J.C. Alencar, F.S.B. Mota, H.L.L. Coelho, "Misoprostol and congenital malformations," The Lancet, Vol. 338, No. 56 (1991), pp. 338-356. C.H. Conzalez, F.R. Vargas, A.B. Perez, et. al. "Limb deficiency with or without Mobius sequence in seven Brazilian children associated with misoprostol use in the first trimester of pregnancy," American Journal of Medical Genetics, Vol. 47, No. 59 (1993), pp. 59-64.

3.) I.M. Spitz, C.W. Bardin, L. Benton, A. Robbins, "Early Pregnancy Termination with Mifepristone and Misoprostol in the United States," The New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), pp. 1241-1247.