FDA To Issue Abortion Drug Warning
RU-486 caution partly in response to local teen's deathNov 16, 2004 | San Francisco Chronicle
The U.S. Food and Drug Administration announced Monday that a strong new warning will be issued for the medical-abortion drug known as RU-486, citing the risk of "rare but serious complications that may occur with any abortion."
The move was in part a response to the case of an East Bay 18-year-old, Holly Patterson, who died in September 2003 after seeking to end her 7-week pregnancy with RU-486.
In a prepared statement and background information released Monday, the FDA made no mention by name of any case but said the agency had received reports of 676 "adverse events" linked to the drug since its approval in 2000, ranging from minor problems such as nausea to five cases of nonfatal but serious bacterial infection and three deaths.
Two of the deaths resulted from bacterial infections, including the Patterson case and another death that occurred in January 2004 but was not reported to the FDA until August because of some confusion as to what drug had been prescribed.
Another death, in September 2001, followed a ruptured tubal pregnancy, a dangerous condition and a type of pregnancy that RU-486 does not terminate.
Danco Laboratories in New York, the maker of RU-486 in the United States, said it agreed to a revised warning and medication guide after extensive discussions with FDA officials. The company is sending letters to medical providers today advising them of the changes.
The FDA said it hasn't established whether the abortion pill directly caused any of the so-called adverse events, emphasizing that life-threatening complications such as severe bleeding and infection may occur "following any termination of pregnancy," whether by miscarriage, surgical abortion or drug- induced abortion.
RU-486, which is known generically as mifepristone and is sold in the United States under the brand name Mifeprex, has been used by about 360,000 women in this country since the FDA approved its use in 2000.
Doctors prescribe it in combination with another drug, misoprostol, as an alternative to surgical abortion in early pregnancy.
The revised "black box" warning in the drug's package insert and other materials includes the first specific language about the risks, including the possibility of death from bacterial infections and septic shock. The "black box" is the agency's most strident alert.
Doctors are advised that serious infections can arise without fever or abdominal tenderness, the usual hallmarks of infection. Patients are told to see their health care provider right away if they experience fever, abdominal pain or heavy bleeding. The new warning also advises patients to bring the drug's medication guide along with them if they seek emergency help.
Monty Patterson, 51, a Livermore contractor and the father of Holly Patterson, said he was sure his daughter would still be alive had the revised label been in place when she was prescribed RU-486 at a Planned Parenthood clinic in Hayward.
"I think Holly would have been able to recognize her symptoms early on," he said during a telephone interview.
Although he has not filed any litigation or joined in any anti-abortion protests of RU-486, Patterson has traveled with family members to FDA headquarters to press his case that his daughter's death might have been avoided with proper precautions. He insisted Monday that RU-486 is unsafe as currently prescribed, calling on the FDA to ban it outright or at least force the drugmaker to conduct additional clinical research.
Nevertheless, Patterson said the new label was a move in the right direction.
"I think (the drug) should be banned, but I am glad the FDA did take this first step," Patterson said.
He also disclosed that he was recently informed that his daughter had died of systemic infection, or sepsis, with the bacterium Clostridium sordellii, which is rarely seen in gynecologic practice.
A recent report in the medical literature from Canada describes another case of a 27-year-old woman who died of the same type of infection, also linked to a medical abortion that apparently went tragically wrong. Patterson called for medical experts to investigate whether RU-486 suppresses the immune system in such a way as to make women vulnerable to C. sordellii.
Dr. Vanessa Cullins, vice president for medical affairs at Planned Parenthood Federation of America in New York, insisted that RU-486 poses no unreasonable risks. She said the new warning label was an appropriate step, saying the new wording was "based on science" and avoided any "alarmist statements."
"There was an attempt here to try to put adverse events into the context of miscarriage and surgical abortion," she said. "It's my hope this information will not scare women away who really want to try this option."
Abortion opponents renewed their demand that the FDA ban the abortion pill. "This is a dangerous drug that deserves to be pulled off the market immediately," Wendy Wright, senior policy director at a Washington group called Concerned Women for America, said in a news release Monday.