FDA Warns Again of Abortion Pill Risk
Jul. 21–News of two more women who died from infection after taking the RU-486 abortion pill have fueled political debate over whether the drug should be pulled from U.S. markets.
Republican lawmakers, who are already trying to suspend government approval of RU-486, said Wednesday that increasing warnings about the drug isn’t enough.
“Clearly, warning labels and letters to doctors are not protecting the life and safety of young American women from this drug,” said Rep. Roscoe Bartlett, R-Md.
The Food and Drug Administration issued a health warning Tuesday on the risk of rare but serious infection following treatment with RU-486, not always accompanied by fever.
It was prompted by reports that a fourth California woman — the first was 18-year-old Holly Patterson of Livermore, who died in September 2003 — has died from infection after taking RU-486 and its follow-up drug, misoprostol.
The warning did not appease lawmakers who had already introduced “Holly’s Law,” which would suspend FDA approval of RU-486 until the federal Government Accountability Office examines the process by which the drug was approved in September 2000.
“Congress needs to act to take this deadly drug off the market and force a serious review of its safety — something that should have been done before it was ever approved,” said Sen. Jim DeMint, R-S.C.
A spokeswoman for Rep. Ellen Tauscher, a Democrat whose congressional district includes Livermore, said Tauscher needs to know more about the most recent deaths before commenting.
Meanwhile, officials with Planned Parenthood Federation of America argued that adverse effects from RU-486 are still extremely low — lower than carrying a pregnancy to full term.
“There is no reason for a change in medical policy and management at this time, although as with any woman who is pregnant, signs of possible infection need to be investigated,” said Dr. Vanessa Cullins, vice president of medical affairs for Planned Parenthood.
A death last year of a woman who took RU-486 prompted the FDA in November to issue its highest category of safety warnings to doctors and consumers. Now, in conjunction with the drug maker, Danco Laboratories, the FDA is adding new information.
Without conclusively saying RU-486 caused the deaths, “We want to make sure that physicians and patients using this drug are aware of the potential risk of overwhelming infection that may occur with this product,” Galston said.
Previously, two U.S. deaths from infection, including Patterson’s, had been reported, and one woman died from infection in Canada during a clinical trial in 2001. But Danco said this week that it learned recently of another death that occurred in late 2003 and another this year.
In all four cases, FDA-approved guidelines for drug-induced abortions were not followed, Galson said. FDA guidelines say RU-486 should be given in the first seven weeks of pregnancy and its follow-up drug, misoprostol, is to be given orally during a second office visit.
But many doctors, on the basis of published studies, prescribe misoprostol in higher doses to be inserted vaginally at home.
Galson stressed it has not been determined that such “off-label” use is responsible for the deaths, and that the FDA has no authority to ban it because it doesn’t regulate the practice of medicine.
He said the rate of fatal infection among women using RU-486 is similar to that for women giving birth or undergoing surgical abortion — about one in 100,000. It is estimated about 460,000 U.S. women have used the pill.
The bacteria determined to have caused deadly infection has been identified as Clostridium sordellii in two of the U.S. cases, including Patterson’s, and is under investigation in others.
The FDA warnings say the bacterial infection can lead to weakness, nausea, vomiting and diarrhea but can lack some usual symptoms of infection, including fever.
Though doctors who suspect a patient has an infection are being advised to give antibiotics immediately, the FDA does not recommend all RU-486 patients be given an antibiotic as a routine precaution.
Galson said it’s not clear why all four U.S. deaths were in California, adding, “It may be just a fluke.”
Monty Patterson, Holly’s father, said it may be due partly to California’s large population, but he believes doctors elsewhere simply aren’t making a connection between deadly infection and RU-486, and that other women may have died. He also contends RU-486 “predisposes women to serious infections and even death because it impairs the immune system.”
Both Cullins of Planned Parenthood and Dr. Cynthia Summers of Danco said no evidence exists to support either claim.
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