TUESDAY, Nov. 16, 2004 (HealthDayNews) -- U.S. Food and Drug Administration officials insisted Tuesday that medical evidence, and not political pressure from conservative groups, prompted their decision Monday to order the most stringent safety labeling for RU-486, the abortion pill.
"We're not really in the business of encouraging or discouraging use of any particular drug," Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said at a news conference. "There was absolutely no political pressure on this. This was a science-based decision, and the way this decision was made was typical of any decision at the FDA having to do with the review of drugs."
The FDA has come under fire in the last several weeks for its alleged failure to act more quickly on other drugs, such as Vioxx and antidepressants in children, that studies had shown to cause harm.
Research revealed in October found that 3.7 percent of patients using Vioxx for at least 18 months experienced at least one type of serious cardiovascular event during the study period, compared to only 1.9 percent of those on a placebo. It was the drug's manufacturer, Merck Pharmaceuticals, that pulled the financially successful drug from the shelves, not the FDA. And it was through lobbying on the part of parent groups and professional organizations -- along with two separate advisory panel recommendations -- that caused the FDA to order the so-called black box warning on all antidepressant prescriptions.
The agency approved RU-486, also known as mifepristone, in 2000 to terminate early pregnancies. Since that time, there have been reports of three deaths in the United States among a total of about 360,000 women who have used the drug. In addition, Galson said, there have been about 600 reports of other adverse events.
Investigators have not been able to definitively link the drug to any of the deaths. "We don't have information to indicate the drug caused the event," Galson added.
The lack of a smoking gun has some experts scratching their heads over the FDA's move. "There's no definite causation link, so it's a little perplexing that they would be doing this," said Dr. Paul Blumenthal, an associate professor of obstetrics and gynecology at Johns Hopkins University and an adviser to Planned Parenthood. "On the other hand, this is a drug that is clearly under the political microscope, and adding on that is recent experience with other drugs. I think that it's probably a part of the era of defensive medicine in which we live -- that it makes some sense to apprise people of risks."
Blumenthal added that the data from nationwide use are "overwhelmingly reassuring" about the safety of RU-486.
The revised black box warning will include more information on vaginal bleeding and on a dangerous blood infection called sepsis. More information on ectopic pregnancy, another potentially deadly condition when a fetus implants in tissue outside the uterus, will appear in the warning section.
The first death, reported in October 2001, involved a 38-year-old woman who was four weeks pregnant with an ectopic pregnancy. RU-486 is not supposed to be used when there is an ectopic pregnancy.
The other two women died of overwhelming sepsis. One of these, 18-year-old Holly Patterson, was infected with the bacterium Clostridium sordellii, said her father, Monty Patterson of Livermore, Calif. It's not clear how that bacterium would be associated with the drug, although Holly's parents believe it may cause suppression of the immune system.
For Monty Patterson, the FDA's moves are welcome but not nearly enough.
"We are pleased that the FDA has finally validated some of our concerns about the RU-486 regimen. However, a lot of work needs to be done -- particularly, we still feel that this drug should be pulled from the market," he said. "We want to know how many young women are going to have to die before the FDA pulls it from the market."
Another 1 million women in Europe have used the drug since it was first approved there in 1988.
Galson said the FDA looks at "the balance of the risks vs. benefits" when deciding whether to pull a drug from the market. "That calculation is very different with every single drug," he added. "It depends on whether the drug is used for serious conditions or less serious conditions. It depends on the level of risk of the drug and the type of adverse event reports that we get in and then we look at whether those adverse events could be prevented. There's no one formula."
Blumenthal certainly agreed that the public and health-care providers should be made aware of any risks with a drug. "We recognize that just because something is safe doesn't mean that it's without risk, and even if the risks are rare, is it worth apprising the public and health-care providers so that people will be vigilant? Yes, it's worth it, but, in that case, they should probably treat all drugs alike. I don't know that there is a black box for Viagra, which has a death rate higher than mifepristone. I do know there is a black box out there for tampons, and that's based on some very, very rare occurrences several years ago. Do I think this will change people's practices? Probably not."
Planned Parenthood issued a statement supporting the FDA's action.
More information
Visit the FDA to learn about its move on mifepristone.
