Danco Laboratories LLC has stated that five women out of over 460,000 women who took its abortion pill Mifeprex or RU-486 or mifepristone, have died from bacterial infections since its introduction in 2000 in the U.S. market.
While the drug maker said that there was “No causal relationship between these events" and the drug, the US FDA warned doctors to be on the lookout for rare but deadly infections in women using the pill, which some believe may have been triggered by non-adherence to the usage instructions.
While one of these five deaths occurred during clinical trial in Canada in 2001, the other four were reported in California between 2003 and 2005, with three of the five cases involving a bacterium Clostridium sordellii which is a common germ not usually associated with illness.
Meanwhile Danco, which is pitted against abortion opponents trying to revoke the drug, said that with these rare infections, it was keen that women who take Mifeprex and misoprostol be able to recognize symptoms early, suggesting that those experiencing abdominal discomfort 24 hours after the pill should contact a doctor or visit an emergency room immediately.
The company in a statement to assuage users of Mifeprex or RU-486, said that childbirth, menstruation and abortion create conditions “that can result in serious and sometimes fatal infection” irrespective of whether spontaneous or induced and there was no evidence that the drug presented “a special risk of infection". In order to terminate a pregnancy of 49 days or less, women are advised to take Misoprostol two days after Mifeprex, which currently carries the warning of a possibility of serious and sometimes fatal infection.
Danco, meanwhile, is sending a letter to alert physicians about the cases and updating warning information on the drug's label, facilitating them to spot the problem. The drug Mifeprex or RU-486, which is approved for use by women barring cases of ectopic pregnancy, up to 49 days after the last menstrual cycle, blocks a hormone that sustains pregnancy, while misoprostol, terminates the pregnancy.
Director at the FDA, Dr. Galson believes that while the FDA's instructions are to swallow both pills, most abortion clinics recommend women to insert the misoprostol tablet into the vagina, which though proven to be effective may result in sepsis. He also opines that women, suffering sepsis after the incorrect use of pills, may not exhibit the typical symptoms such as a fever but suffer nausea, vomiting, diarrhea and weakness. With four sepsis deaths, all reported from California, after this so-called off-label use, there is a need to conclusively prove that the women had inserted the tablet vaginally themselves. Another physician Dr. Summers said that the same infection has been reported after childbirth and in other gynecological situations.
Dr Galson opines that the 1 in 100,000 rate of sepsis of the Mifeprex system is comparable to infection risks with surgical abortions and childbirth, making the abortion pill safe enough to stay on the market. The other death associated with drugs was a case of a ruptured ectopic, or tubal, pregnancy in October 2001. However, Wendy Wright, Director at Concerned Women of America, a women's group said that label changes are not sufficient to make the drug safe as those who support the drug “believe the risk of death is preferable to having a child".
