Citing studies indicating the birth control patch increased the risk of dangerous blood clots, Public Citizen has petitioned the agency to withdraw the Johnson & Johnson product over a six-month transition period in which the healthcare giant is urged to release a newer formulation. (Look here).

The consumer group argues that Ortho-Evra results in 60 percent more estrogen on average exposure; greater variability in estrogen levels; a possible two-fold increased risk of venous thrombosis; increased risk of side effects such as breast discomfort, severe menstrual pain, nausea, and vomiting; a 50 percent increased likelihood of discontinuation, and no improvement in contraceptive outcomes.

The move comes four months after the FDA upgraded the warning on the labeling to include results of an epidemiology study that found that Ortho-Evra users were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. Lawsuits, meanwhile, have charged J&J with allegedly misleading docs and the FDA for years by altering and withholding medical data about the patch.

Estrogen used in contraceptives has long been known to increase the risk of blood clots, which can trigger heart attacks or strokes. Women who use Ortho Evra are exposed to about 60 percent more estrogen than pill users. “If Ortho-Evra had been designed as a pill, it is unlikely to have been approved because of its increased estrogen content,” Sid Wolfe of Public Citizen tells Reuters.

The FDA says the chance of developing a clot is low. For every 10,000 women who use hormonal contraceptives for one year, some three to five of them will develop a clot, the agency has said.
Abbout 2.7 million scrips were written, according to data cited by the petition, and more than 9.9 million scrips were written in 2004.

“Without any additional efficacy and considerable additional risk beyond the accepted levels from pills, Ortho-Evra is a poor choice for women. Yet the patch is still vastly superior to no contraception at all,” the petition states.

“Withdrawal of any contraceptive from the market carries the risk that some proportion of users will not immediately replace their contraception with a method that is as effective as the banned product. Ideally, J&J could immediately release a safer reformulation of the patch that delivered lower and less variable levels of estrogen, although this has not happened in the seven years Ortho-Evra has been available.

“Public Citizen therefore requests a six-month transition period in which Ortho-Evra will be available for refill prescriptions to allow women time to meet with their healthcare provider and seek an alternative contraceptive method.”