RECENT CLINICAL UPDATES - from mamah.org Recent news stories about the risk of blood clots and strokes in women using the birth control patch have raised women's concerns about the safety of this product. Blood clots are a known and serious risk of all hormonal contraception, but it's not a common risk. And with full information the National Women's Health Network believes that women can make good decisions for themselves about whether the benefit of using hormonal contraception outweighs the risk for them. According to reports filed with the Food and Drug Administration (FDA), at least 12 women who were using the patch have died as a result of blood clots. An analysis of these reports appears to indicate that the risk of blood clots is greater for women using the patch than for women using birth control pills. Drug safety at the FDA Because the FDA's reporting system is voluntary and has other significant weaknesses, it's not possible to draw reliable conclusions from these reports about how rare or common the problem with the patch is. But women do need to know. The National Women's Health Network has written to the FDA, urging the agency to conduct a study to look at the risk of blood clots associated with use of the Ortho Evra birth control patch. The fact that such a study was recommended by an FDA medical reviewer at the time of the product's approval but not required by the agency is further evidence of the need for safety reforms at FDA to give greater authority, independence and resources to the agency's post-market safety monitoring system. Risk information for women In the meantime, women should be given full information about what is known about the safety of the patch. Health care providers should help women understand the meaning of the evidence about this health risk as well as any factors that might make an individual woman more likely to experience a problem. For example, the risk of experiencing blood clots increases with age, obesity and inherited clotting disorders. To understand the meaning of the risks being discussed, some women find it useful to frame the facts in terms of the absolute number of women affected: A woman who is younger than 35 is very unlikely to get a blood clot; her risk is between 2 and 5 in 100,000. If she's taking the type of pill most commonly prescribed in the United States, her chance of getting a blood clot is between 8 and 18 in 100,000; and her chance of dying from a blood clot while taking the pill is about 1 in 500,000. If using the patch increases the risk as much as the news stories suggest, her chance of getting a clot would rise to between 24 and 54 in 100,000 and her risk of dying from a clot would be about 3 in 500,000. The option of the patch The patch offers advantages over other hormonal contraceptives that women value because it eliminates the need to remember to take a pill every day, yet gives women more control than contraceptive injections or implants. To preserve safe options for women, it is critically important for the FDA to ensure that the information necessary to make a fully informed decision about the benefits and risks of this method is known and available. -NWHN To learn more go to: http://www.nwhn.org/alerts/alerts_details.php?aid=42 Disclaimer: The above represents the author’s opinion and is intended for the use of clients of the Midwives at Mount Auburn. It should not substitute for the advice of your own care provider.