Another Blood Clot Warning for Ortho EvraFeb 1, 2008 | Parker Waichman LLP
Ortho Evra, Johnson & Johnson’s defective contraceptive patch will now include yet another new warning on blood clots. Information received from a second study that revealed a higher risk of blood clots compared with birth-control pills will be included in the patch’s packaging, according to a statement from U.S Food & Drug Administration (FDA).
In 2006, the prescribing instructions for the Ortho Evra patch were revised to include information about a study warning that women could face a doubling of blood clot risks when using the patch. Previous to that study, Johnson & Johnson had touted a study that inidcated that Ortho Evra’s blood clot risks were equal whether one took the Pill or wore the contraceptive patch.
The FDA said the newest findings backed earlier concerns that patch users might face even greater dangers than women who take the pill. "Even though the results of the three studies are conflicting, the results from two of the studies support the FDA's concerns regarding the potential for use of Ortho Evra to increase the risk of blood clots in some women," an agency statement stated.
The most recent study of women ages 15 to 44 also found blood clots—also known as venous thromboembolisms or VTEs—were about twice as likely to develop in women who used the patch versus women who took birth control pills, the FDA said. Yet despite the increasing evidence of a high blood clot risk, the agency said it believes "Ortho Evra is a safe and effective method of contraception, when used according to the labeling." The Ortho Evra Patch’s labeling recommends that those women with concerns or risk factors for serious blood clots speak with their doctors before wearing the patch. "Women should discuss with their health-care provider the possible increased risk of VTE with Ortho Evra, which is applied once a week, and balance this risk against the increased chance of pregnancy if women do not take their birth control pill daily," the FDA said.
It is a well-known fact that the estrogen used in contraceptives raises the risks of blood clots, which can lead to heart attacks or strokes. Hormones from the once-a-week Ortho Evra patch—norelgestromin and ethinyl estradiol (progestin and estrogen) are released into the blood stream through the skin and processed differently than the hormones from birth control pills. Women who use the Ortho Evra patch are exposed to about 60 percent more estrogen than pill users, thus raising the risks of these adverse affects. .
Ortho Women's Health & Urology, the Johnson & Johnson division that manufactures the Ortho Evra contraceptive patch, said in a statement that it worked with the FDA on the label change. "Ortho Evra, like all hormonal birth control, has risks and benefits. It is important that women speak to their health-care professional to determine the option that is right for them," the company said.