July 28, 2005
WASHINGTON (BP)--Critics of RU 486 again are calling for its removal from the market after two previously unreported deaths were disclosed by the abortion drug’s manufacturer.

Danco Laboratories in New York revealed July 18 that women in California had died in 2004 and in 2005 after using the two-step drug regimen to abort their unborn children. Danco has acknowledged two other California users of RU 486 died in 2003 and a Canadian woman died after its use in 2001. Other reports have cited additional deaths by RU 486 users -- three in Europe, one in the Philippines and another in the United States.

Danco announced it would update the safety information on the label for Mifeprex, the American brand name for RU 486, which is also known as mifepristone. The label already contains a “boxed warning,” the Food and Drug Administration’s highest level of warning on a federally approved drug. The deaths were from bacterial infection and sepsis, according to Danco. Sepsis is a systemic reaction to infection that can result in organ failure and death.

The FDA issued a public health advisory regarding off-label use of the drug the day after Danco’s announcement and said it would begin an investigation.

Those steps were not sufficient for critics of RU 486 inside and outside Congress.

Rep. Roscoe Bartlett, R.-Md., urged his fellow representatives to support his RU 486 Suspension and Review Act, H.R. 1079, which would halt sale of the drug while FDA approval of RU 486 is reviewed. The bill is known as Holly’s Law in memory of Holly Patterson, 18, who died of a systemic infection in 2003 after obtaining RU 486 from a Planned Parenthood clinic in Hayward, Calif.

“Clearly, warning labels and letters to doctors are not protecting the life and safety of young American women from this dangerous drug,” Bartlett said in a written statement. “I hope there will be no more deaths reported before Congress approves Holly’s Law.”

David Stevens, executive director of the Christian Medical Association, said in a written release, “With every death of another woman due to RU 486, the FDA’s mandate grows clearer –- to pull this drug for an objective safety review.”

Bartlett’s bill has 73 cosponsors, while a Senate version, S. 511, has only nine cosponsors. Sen. Jim DeMint, R.-S.C., is the sponsor of S. 511.

RU 486, or mifepristone, is used as the first part of a process normally occurring in the first seven weeks of pregnancy. That initial action causes the lining of the uterus to release the embryonic child. A second drug, known as misoprostol, is taken two days after mifepristone and causes the uterus to contract, expelling the baby. Misoprostol normally is used to treat ulcers.

Pro-life organizations, including the Southern Baptist Ethics & Religious Liberty Commission, fought introduction of RU 486 into this country for more than a decade before the drug was approved by the FDA in 2000, the final year of President Clinton’s second administration.