May 8, 2008
(Foodconsumer.org) — Public Citizen today submitted a petition to the Food and Drug Administration asking the agency to pull off Ortho-Evra Patch, a contraceptive made by Johnson and Johnson, from the market in six months.
In a statement, the consumer advocate said women who used the patch were twice as likely to develop blood clots as those who used other types of standard oral contraceptives.
Public Citizen said the reason it asked the FDA to complete the withdrawal within six months rather than immediately is because it fears that women who are on the drug may not be able to swift to use of other types of contraceptives as quickly they should.
The problem with this drug, according to the organization, is that Ortho-Evra Patch exposes women to dangerous estrogen levels. The finding was based on unpublished studies that have been released due to ongoing litigations.
Compared to standard oral contraceptives, Ortho-Evra exposes women to “more estrogen and a greater range of estrogen levels; a possible two-fold increase in the risk of blood clots; increased painful side effects such as breast discomfort, severe menstrual pain, nausea and vomiting; an increased likelihood of discontinued contraceptive use; and no improvement in contraceptive outcomes.”
The overall exposure to estrogen from the Ortho-Evra patch was 55 to 60 percent higher from the patch than a standard estrogen oral contraceptive, according to the nationâ€™s most powerful consumer group. Absorbed amounts of estrogen from the patches were 1.2 to 3.5 times higher compared to the oral contraceptives.
High exposure to estrogen is known to be risky for women. More women who wore the patches complained they experienced breast discomfort, painful periods, nausea and vomiting and discontinuation than women who used oral contraceptives.
Studies have found women using the patch had an up to two-fold increase in risk of blood clots compared to those who used standard oral contraceptives.
“Women deserve a level of risk at least comparable to or less than the pill for their hormonal contraceptive,” said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen.
“The absence of any evidence of a unique benefit combined with the considerable safety problems of high-dose, variable estrogen exposure in Ortho-Evra tips the balance of risks and benefits against its availability as a contraceptive.”