FDA Data on RU-486 Spotty, Inconclusive

July 7, 2008 - 8:03 PM

(CNSNews.com) - The abortion pill RU-486 can have serious side effects and complications, but the federal government's requirements for data collecting appear to do little to help advocates on either side of the issue make their case about the safety of the drug.

Food and Drug Administration data obtained by CNSNews.com through the Freedom of Information Act (FOIA) regarding reports of adverse side effects using RU-486 show only 33 individual reports entered into the FDA database during a four year period between November 1997 and November 2001.

The data represent "side effects and complications arising from the use of RU-486 during the time it has been available in the U.S. Market," wrote Debra P. Taub, lead consumer safety officer for the Department of Health and Human Services.

Patients taking one or both of the two-drug combination included men and women, ranging from teenagers to people in their 70s.

The data do not specifically state the purpose for taking the drug; some women appeared to be taking the drug for abortion purposes, based on the dosages taken, while others used the drug to treat medical problems unrelated to abortion.

Four men and 29 women were among those whose cases were referred to the FDA, and the data show that five patients for whom an adverse side effect was reported died, with RU-486 or one of its components listed by doctors as the primary suspected cause of death.

Among those reported deaths, three were men, representing 75 percent of all the men included in the adverse side effect report.

Other adverse effects for which doctors listed RU-486 as the primary suspect included nausea, dizziness, excessive bleeding, life-threatening blood clots and infection, and respiratory distress.

Not counting the two women who died with RU-486 listed as the prime suspect, responses to the various side effects among women included 22 who required hospitalization or "intervention to prevent permanent impairment," and five who experienced "life threatening" or "other" medical outcomes.

Reports More Anecdotal Than Empirical

Federal law requires all drug manufacturers to make such reports to the Food and Drug Administration (FDA). It's a reporting system the FDA and others say helps regulators keep an eye on a drug's side effects.

However, doctors are not required to report their findings to drug manufacturers, a regulatory loophole that renders the data collecting spotty and far from complete.

John Diggs, a pro-life Massachusetts doctor and advisor to the Family Research Council, sees cause for alarm in the FDA data. "The number one problem is that the drug is really bad," said Diggs.

"I am not surprised [at the adverse effects], because these are the expected complications," he said. "The problem is the FDA chose to overlook them."

Diggs and other pro-life advocates have been critical of the FDA for giving RU-486 fast track approval in September 2000, using an expedited process typically afforded drugs that have life-saving potential.

"Any drug like this that's causing those number of deaths under any other circumstances would be withdrawn or at least studied," he said. "But this one was pushed through under fast track, meaning that it bypassed all the usual studies and the time and the peer review to make sure that a drug is safe."

It's not known whether there's a direct link between the streamlined approval process and the collection of 33 reports of adverse side effects over a four-year period.

The drug's direct and indirect health complications were "completely preventable and foreseeable, and many people commented on it before it was approved," Diggs said.

At the very least, he said, the FDA should have required doctors to perform an ultrasound before prescribing the drug for abortion purposes, in case the patient has an ectopic pregnancy, where the fetus attaches itself to the fallopian tube rather than the uterus. Ectopic pregnancies, Diggs explained, cannot be terminated without surgical abortion.

Direct Side Effects or Medical Coincidence?

Abortion rights advocates, however, see something different in the government data. Dr. Beverly Winikoff contends that RU-486 is relatively safe.

She serves as director of reproductive health for the Population Council, the group that spearheaded the effort to gain FDA approval for RU-486.

"I don't know who can vouch for the accuracy of all this," Winikoff said, looking at the FDA data. "There can be errors in data entry," she suggested, though "one has to assume that they're probably generally accurate."

Winikoff, like Diggs, noted that drug side effects are almost certainly under-reported, since the FDA does not require doctors to do so. But she said the reporting requirements during a drug's initial clinical study are rigorous enough to identify most side effects and complications before the drug is approved.

In addition, Winikoff claimed complications reported to the FDA were not all caused by RU-486 itself. In one case, a 15-year-old girl was hospitalized for pulmonary and leg blood clots after taking RU-486.

"She had an infection, it looks like," said Winikoff, reading the girl's long list of medical complications. "That could have come from something that was done to her in the hospital when the other stuff was being treated.

"These are not side effects," she explained. "This list is a list of things that happened to women who took this drug for any reason, and it's anything that happened to them after they took the drug. But it's not necessarily a drug side effect."

Although Winikoff wouldn't necessarily consider some medical situations as side effects of RU-486, she didn't completely discount the potential for a link. "It's always a risk of any kind of abortion that someone can have an infection. So, yes, this could be related to the abortion," she said.

The bottom line, says Winikoff, is that RU-486 is a relatively safe drug for women to use. "Death is a possibility from life," she said. "We know from many years of record keeping that death is a possibility with surgical abortion but a very rare one. It occurs mostly from infection, hemorrhage or anesthesia reaction."

Over many years of experience with RU-486 in Europe, she said, women should feel confident that the drug is a relatively safe way to end a pregnancy.

E-mail a news tip to Christine Hall.

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See Related Stories:
Abortion Pill Anniversary Brings Surprises (Sept. 28, 2001)

Canadian Woman Dies in RU-486 Trial Run (Sept. 19, 2001)

FDA Criticized for Playing Politics, Downplaying Risk of RU-486 (Dec. 1, 2000)