Health Care

FDA Investigating Two Deaths from Abortion Pill

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The Food and Drug Administration says it is investigating two more deaths associated with the abortion pill RU-486. In the wake of the announcement, Planned Parenthood announced it would change the way it administers drug-induced abortions. And abortion opponents are stepping up their calls for the drug to be pulled from the market.

The latest reports bring to seven the number of reported deaths following drug-induced abortion. That's out of more than half a million performed since the pill was approved in September 2000.

It's not clear what caused the latest two deaths, but four of the five earlier deaths — all women in California — were the result of a rare bacterial infection. And in those four cases, the second drug in the two-drug regimen was administered vaginally rather than orally.

"All four cases were women who had received this treatment vaginally, who then all quickly reported back to their physician with very serious, rapidly spreading infection which led to sepsis and death, unfortunately," said a spokeswoman for the FDA. The agency is asking that its spokespeople not be identified by name for personal-safety reasons because of previous threats to FDA staff.

Last fall, the FDA reminded doctors that vaginal use of the second drug, called misoprostol, is not what the agency formally approved. The drug is supposed to be taken orally. On Friday, the agency repeated that directive.

"We felt it was urgent to reiterate yet again what is the only approved method for safe administration of RU-486: oral administration followed carefully by their physicians with follow-up on day 14" to make sure the abortion is complete, said the spokeswoman.

Vanessa Cullins, M.D., Vice President for Medical Affairs for the Planned Parenthood Federation of America, said there was good reason for the vaginal use that its clinics had been recommending.

"The vaginal route has less side effects and also enables women to have medical abortions up to 63 days, as opposed to the 49 days that the oral route is approved for," she said.

But as of Friday, Cullins said, Planned Parenthood has banned vaginal administration of misoprostol in its clinics.

"We're making this change because we're being very cautious. The health and safety of our patients is Planned Parenthood's top priority," she said.

Cullins stressed that Planned Parenthood will continue to offer medical abortion, but that the misoprostol will be administered orally. She said that even with the risks, medical abortion remains far safer than carrying a pregnancy to term.

But abortion opponents disagree. They've been pushing a bill in Congress that would withdraw approval of RU-486 pending a new safety review. Rep. Chris Smith, (R-NJ) contends that deaths from the drug are being underreported.

"It's being listed as sepsis, or some other infection. In the case of California, we might not have caught that if the coroners were not on the ball about the very serious problems of RU-486, which is just another baby pesticide that's being used," Smith said.

The FDA says it will release details about the circumstances of the latest deaths as soon as it receives them.



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