Two more die after abortion-pill use

WASHINGTON — Two more women have died after using the abortion pill RU-486, regulators said Friday in a warning that brought renewed calls to pull the drug from the market.

The organization that provided the pill to the two women said it would immediately stop disregarding the approved instructions for the pill's use.

The Food and Drug Administration (FDA) warned doctors to watch for a rare but deadly infection previously implicated in four deaths of women who had taken the drug. The drug, sold as Mifeprex or mifepristone, has not been proved to be the cause in any of those cases.

Nor has the FDA confirmed the cause of the latest two deaths. However, in one, the woman's symptoms appeared to resemble those in the four California cases in which the women died from an infection of the bloodstream, or sepsis.

Those women did not follow FDA-approved instructions, which require swallowing three tablets of one drug, followed by two of another two days later.

Instead of swallowing the final two tablets, the second course of pills was inserted vaginally in the four women, an "off-label" use that has been recommended by a majority of the nation's abortion clinics. That use does not have federal approval though studies have indicated it produces fewer side effects.

It was not immediately known if the second course of pills had been inserted vaginally in the two latest women to die, an FDA spokeswoman said. She declined to be identified.

Where the latest deaths occurred was not disclosed.

Two Senate abortion foes, Republicans Jim DeMint of South Carolina and Tom Coburn of Oklahoma, urged passage of legislation that would suspend sales of RU-486 until the Government Accountability Office reviews how the FDA approved the pill.

"This drug should never have been approved, and it must be suspended immediately," DeMint said.

Monty Patterson, a California man whose daughter, Holly, 18, died in 2003 after taking the pill, also said the drug should be pulled from the market. The Senate bill is informally called "Holly's Law."

Meanwhile, Planned Parenthood Federation of America said it would immediately stop recommending vaginal insertion of pills.

Four of the women who died, including the latest two, received the pills at Planned Parenthood-affiliated clinics, said Dr. Vanessa Cullins, the organization's vice president for medical affairs. Planned Parenthood estimates RU-486 has been used 560,000 times in the United States since it was approved in 2000.

More than 1.5 million women have used the pill in Europe, FDA officials said. Risks of death from infection are similar to the risks after surgical abortions or childbirth, FDA officials said.

RU-486 is sold by Danco Laboratories and is approved to terminate pregnancy up to 49 days after the beginning of the latest menstrual cycle. It blocks a hormone required to sustain a pregnancy. When followed two days later by another medicine, misoprostol, to induce contractions, the pregnancy is terminated.

At least seven U.S. women have died after taking the pill. The other U.S. death associated with Mifeprex was the 2001 case of a ruptured ectopic, or tubal, pregnancy. The drug is not to be used in those cases, in which the fertilized egg implants outside the uterus.

In the California cases, all four women tested positive for Clostridium sordellii, a common but rarely fatal bacterium.

Federal health officials plan a May 11 workshop in Atlanta to discuss emerging cases of disease involving the germ, which also have included infections in patients who have received skin grafts.