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Kaiser Daily Women's Health Policy
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Bioethics & Science | Study Put Pregnant Women at Risk by Giving Them Placebo Rather Than Alternative Herpes Drug, Advocacy Group Says
[Dec 05, 2006]

     In a recent clinical trial to test the efficacy of GlaxoSmithKline's herpes medication Valtrex, 168 pregnant women were put at risk when they were given a placebo rather than an alternative herpes drug, Peter Lurie and colleagues from the consumer advocacy group Public Citizen wrote in an letter published in the Dec. 1 issue of the journal Obstetrics & Gynecology, the AP/Seattle Post-Intelligencer reports. The American College of Obstetricians and Gynecologists, which publishes Obstetrics & Gynecology, since 1999 has recommended that Valtrex, known generically as acyclovir, be considered as a treatment for women who experience their first genital herpes outbreak while pregnant (Bridges, AP/Seattle Post-Intelligencer, 12/1). George Wendel and colleagues from University of Texas Southwestern Medical Center in a 2003 issue of Obstetrics & Gynecology published a study of existing research that concluded that giving acyclovir to women at 36 weeks' gestation reduced the risk of genital herpes outbreaks at delivery and the need for caesarean sections, the Dallas Morning News reports (Meyer, Dallas Morning News, 12/2). Wendel and colleagues in a study published earlier this year in Obstetrics & Gynecology found that 4% of pregnant women who received Valtrex needed a c-section, compared with 13% of pregnant women who received a placebo. The study, which was funded by GlaxoSmithKline, enrolled more than 300 black and Hispanic pregnant women at Parkland Hospital in Dallas. Researchers gave valacyclovir to 170 pregnant women and gave 168 women placebo pills.

For current women's health policy news, visit the National Partnership for Women & Families' website.


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