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Contraceptive Watch


Birth Control Patch Dangerous to Women’s Health

One of the latest birth control methods, the Ortho Evra birth control patch, appears to be more dangerous to women’s health than the Food and Drug Administration (FDA) believed when it approved the device for public use. The FDA recently warned that users are exposed to higher hormone levels than previously believed, leaving users at a higher risk for blood clots and other side effects.

Until recently, Ortho McNeil maintained the patch was expected to have similar hormonal risks as birth control pills. But a strongly worded warning was added to the patch label in November 2005, stating that women using the patch are exposed to about 60% more estrogen than those using typical birth control pills. The warning was added four months after the Associated Press (AP) reported patch users suffer from blood clots and die at a rate three times higher than birth control pill users.

Although most pills and the patch contain the same amount of estrogen, hormones from the patch flow directly into the bloodstream while contents of birth control pills are digested, releasing less than half the amount of estrogen into the bloodstream. The result is that patch users have much higher levels of estrogen in their bodies, says Dr. Leslie Miller, an associate professor of obstetrics and gynecology at the University of Washington, Hormone levels in pill users are highest shortly after taking it, Miller said, so the body is not exposed to high levels of estrogen 24 hours a day. But the patch emits higher estrogen levels all day, increasing some women’s risk of blood clots. Since the patch first went on sale in 2002, it is estimated that over 4 million women have used it.

See the Source: Martha Mendoza, “Warning Issued for Birth-Control Patch,” Associated Press, 11 November 2005, http://www.lasvegassun.com/sunbin/stories/thrive/2005/nov/11/111102566.htmli

RU-486 Deaths Under Investigation

In the September-October 2005 issue of PRI Review (page 9), we reported on the research on bacterial infection caused by RU-486 to women done by Dr. Ralph P. Miech of Brown University. The FDA has finally caught up with the problem as witnessed by the drug again being in the news.

The use of the abortion drug Mifeprex, better known as RU-486, is now under investigation by federal drug regulators after four women in this country died from bacterial infections after using the drug.

These experts hope to explore whether (not relying on Dr. Miech’s research, but feeling they need to reproduce his work) the abortion pill Mifeprex makes patients vulnerable to Clostridium sordellii, a lethal bacteria. If the drug officials find the connection to be valid, they will explore how such an infection “could be more easily diagnosed and even prevented,” according to an official.

Although deaths have been proven to be connected with RU-486, there is no indication that the FDA is considering restricting access to the drug at this time, although the government agency has advised doctors against giving antibiotics as a precaution to prevent the rare infection since antibiotic therapy carries its own risks.

Clostridium sordellii infects the woman’s uterus, where it flourishes and then enters the bloodstream. The bacterium can cause nausea, vomiting, diarrhea and weakness, but it may not bring on fever so the victim often fails to realize how sick she is until it is too late and she succumbs to toxic shock. Antibiotics are often ineffective once the infection has taken hold because even in death, the bacteria release toxins.

Despite the lack of restrictions by the FDA, warnings concerning the possibility of a link between the drug and Clostridium sordellii have been sited on Mifeprex’ s label since July 2005, and the drug agency recently updated this information on its website. Mifeprex, which was approved for use in the United States in September 2000, has been used in more than 500,000 medical abortions. Mifeprex is sold through physicians, who dispense the drug directly to patients. Physicians are required to give their patients a medication guide that lists the drug’s risks.

Wendy Wright, executive vice president of Concerned Women for America, said the news of the Mifeprex deaths proves that the drug is unsafe. “I’m pleased that the FDA is taking a serious look at this,” she said, “and hope that they will no longer allow this drug to be available to cause the deaths of more women.”

See the Source: Gardiner Harris, “Deaths After Abortion Pill to Be Studied by Officials,” The New York Time, 23 November 2005, http://articles.news.aol.com/news/article.a.dp?id=20051123092309990005&_mpc=news.10.1&cid=842.

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