The deaths of four California women who were taking... Danco Laboratories\' Mifeprex -- known generically as mifepristone, which when taken with misoprostol can cause a medical abortion -- were linked to toxic shock caused by the bacterium Clostridium sordellii, but the risk of infection in conjunction with taking the drug is \"low,\" according to a report published on Thursday in the New England Journal of Medicine, the Baltimore Sun reports (Rockoff, Baltimore Sun, 12/1). FDA in July issued a public health advisory warning physicians to watch for any signs of sepsis or other infections among women taking the drug -- which FDA approved in 2000 for the termination of pregnancies of 49 days or less. FDA officials on Nov. 4 updated the warning on the agency\'s Web site after they discovered that the deaths of four California women who took the drug all were caused by C. sordellii, a rare and deadly bacterium (Kaiser Daily Women\'s Health Policy Report, 11/28). The report found no direct link between the deaths of the four women, who received prescriptions at different clinics throughout the state between 2003 and 2005. It also found that the drugs they received came from different manufacturing lots (La Ganga, Los Angeles Times, 12/1). CDC said the one factor that ties the four cases together is that misoprostol was administered vaginally instead of orally. Vaginal administration of misoprostol is considered \"off-label use,\" which is allowed but not recommended by FDA (Kaiser Daily Women\'s Health Policy Report, 11/23). The researchers note that additional data need to be gathered to \"evaluate ... possible association between medical abortion and C. sordellii infections,\" adding that the four cases \"demonstrate that serious infection can occur after medically induced abortion, much as it can occur after childbirth, spontaneous abortion and surgical abortion.\" They add the cases point to a \"need for physician awareness of this syndrome\" (Fischer et al., NEJM, 12/1).
In an accompanying NEJM editorial, Michael Greene -- a professor of obstetrics, gynecology and reproductive biology at Harvard Medical School -- said that the four California deaths are \"tragic,\" but in comparison with the hundreds of thousands of women who are estimated to have used Mifeprex safely, they \"remain a small number of rare events.\" Officials who regulate drugs should keep this \"in perspective\" and not \"overreact to scant data by prematurely foreclosing the only approved\" nonsurgical option for abortion, Greene writes, adding that providers and patients must be informed of the potential risks of the drug and \"be vigilant\" in looking for symptoms of toxic shock after taking it (Greene, NEJM, 12/1).
WBUR\'s \"Here & Now\": The segment includes a discussion with Monty Patterson, whose daughter died of a bacterial infection in 2003 after being administered RU-486. Patterson has filed a lawsuit against the Population Council, a not-for-profit that developed the drug and held clinical trials in Canada. In addition, the segment also includes a discussion with Greene (Young, \"Here & Now,\" WBUR, 12/2). The segment is available online in RealPlayer.
NPR\'s \"All Things Considered\": The segment includes comments from Greene and CDC epidemiologist Marc Fischer (Neighmond, \"All Things Considered,\" NPR, 11/30). The segment is available online in RealPlayer.
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