Drug Company Could Effectively Block RU 486 
Source: Fox News; October 13, 2000

More On This Subject:  Read the Warning Letter from Searle Pharmaceutical to Health Care Providers

New York -- The rollout of the recently approved "abortion pill" RU 486 may be held up by an unexpected source: the manufacturer of a drug inappropriately used in the abortion process.

The abortion drug known as RU-486 and sold under the name Mifeprex can't be used on its own. Mifeprex kills the unborn child, but women must also take a Searle Pharmaceuticals drug called misoprostol to induce a miscarriage and remove the dead unborn child.

But misoprostol was actually designed as an ulcer drug, and Searle doesn't want it used any other way because it presents medical dangers to women.

On Aug. 23, more than a month before RU-486 was approved by the Food and Drug Administration, the company sent out a strongly worded letter, with the cooperation of the FDA, saying misoprostol "is not approved for the induction of labor or abortion." The letter said misuse of the drug can cause adverse effects such as a ruptured uterus, vaginal bleeding and "maternal or fetal death."

Misoprostol has also been used for at least seven years as a cheap and effective way to induce labor, independent of its role in drug-induced abortions.

Despite Searle's objections, the FDA approved use of the drug in conjunction with RU-486, which could pave the way for numerous cases of abortion complications to women, possibly including death.

Searle's action "will cripple the use of RU-486" if it is honored by doctors, charged Dr. Charles Lockwood, chair of the obstetrics committee at the American College of Obstetricians and Gynecologists (ACOG). "We're very concerned by the timing of the letter, coming within weeks of the approval of RU-486 by the FDA."

Pro-life advocates have critized ACOG's recent letter, citing concerns that it is, once again, favoring abortion. Searle declined to comment on the non-ulcer uses of misoprostol. And despite the company's concerns, abortion advocates may continue prescribing the medicine as they like.

"To be fair to Searle, they're being placed right in the middle of a maelstrom," Lockwood said. "They created a wonderful ulcer drug, and that was all they wanted. But it turns out to be a great drug [for abortions]."

RU-486 opponents argue the Searle letter proves their argument the drug-induced abortion method is simply too dangerous. Pro-life Sen. Tim Hutchinson (R-AR) and Rep. Tom Coburn (R-OK) have introduced a bill that would create additional restrictions on Ru 486.  "The debate has more to do with how the FDA steamrolled the process," said Coburn's press secretary, John Hart. "The FDA wrote the letter to give Searle legal protection in future lawsuits from women who will be harmed by the two-drug combination."

ACOG sent Hutchinson and Coburn a letter Thursday insisting misoprostol "helps ensure the delivery of healthy babies and helps ensure the health and the life of the mother." But that argument wasn't working with RU-486 opponents. ACOG's argument is simply "a cover story to promote access to abortion," according to Hart.