05/19/2008- Public Citizen has asked the FDA to require Johnson & Johnson (J&J) to remove its birth control patch Ortho-Evra from the market within six months due to increased blood clot risks.
In a recent petition to the agency, Public Citizen says compared with standard oral contraceptives that contain less estrogen, Ortho-Evra (norelgestromin and ethinyl estradiol) increased users’ risks of blood clots; painful side effects such as breast discomfort, severe menstrual pain, nausea and vomiting; and the likelihood of discontinued contraceptive use.
In 1988, the FDA requested the withdrawal of oral contraceptives with estrogen levels higher than 50 micrograms because of the risk of blood clots, the group says, noting that the patch contains estrogen equivalent on average to a 56-microgram pill.
Public Citizen requests a six-month transition period in which Ortho-Evra would be available for refills, allowing women time to seek alternative contraceptive methods.
J&J contends Ortho-Evra is safe and effective when used in accordance with FDA-approved labeling. “All hormonal birth control methods have benefits and risks, and the approved Ortho-Evra product label has always stated the known risks associated with its use,” J&J says in response to the consumer group’s concerns.
