Manufacturer Issues Warning on RU-486 Component

Source: Stuart Shepard

Date: October 20, 2000

Opposition to the recently approved RU-486 abortion drug is coming from a surprising source: the manufacturer of one of the drugs used in the procedure. RU-486, the so-called "abortion pill," is actually two drugs administered in series. The first drug is mifepristone. The second drug, Cytotec, though designed and officially approved to prevent ulcers, is actually used to induce a miscarriage. In a warning letter, Searle, Cytotec's manufacturer, urges doctors not to use it "off-label" for induction of labor and abortion. The letter states such use can lead to severe bleeding, uterine ruptures that require surgery, or even the death of the mother. "This could turn out to be a silver bullet for opponents of RU-486, because right now the Cytotec is the only drug that's available to accompany RU-486 for the abortion process," said Carrie Gordon Earll, bioethics analyst for Focus on the Family. "I think the company has some real concerns about litigation," she added. "They don't want there to be a complication with misuse of this drug, and then someone to come back and sue them." Brad Beck, M.D., director of outreach to physicians at Focus on the Family, received the letter from Searle. He said it is very unusual to get warning letters such as this, for an off-label use. Generally, drug companies quietly welcome off-label use because it helps the bottom line. "I can't remember an instance where a drug company specifically sent a letter saying not to use (a drug) in this particular manner," Beck said. It is not illegal for a doctor to prescribe a drug for something other that its intended use. However, Searle clearly indicates it has not and will not seek FDA approval for Cytotec to be labeled for use in abortion. Meanwhile, the main component of RU-486 is reportedly being manufactured in China. No U.S. drug manufacturer was willing to take it on. Pro-life advocates have expressed concern about the quality control of a Chinese manufacturing plant making drugs for the United States.