Health
Birth control patch risks shown
NEWS IN BRIEF — Posted March 13, 2006
Users of the birth control patch Ortho Evra had an increased risk of developing blood clots compared with women who took birth control pills, according to preliminary results of an epidemiologic study by the manufacturer of the once-a-week patch.
The Food and Drug Administration said it would not take any action yet. "We should caution that these results are preliminary and further evaluation is necessary to understand what these results mean," said Daniel Shames, MD, director of the FDA's division of reproductive and urologic drug products.
The company has conducted two studies to evaluate the risk of serious side effects for patch users. The first found that the risks of thromboembolic events was the same for patch and pill users. Ongoing evaluation also suggests that there is no difference in the risk of heart attack or stroke.
The second study, which is still being evaluated, has shown a two-fold increase in the risk of venous thromboembolic events for patch users. The study also shows that risks of heart attack and stroke are apparently similar for users of each product.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2006/03/13/hlbf0313.htm.