Warning Added To Address Advantage Appliance
Ortho Evra, the address advantage bark patch, will get a new bolded admonishing advertence that the appliance provides a academy acceptance to estrogen than address advantage pills.
"Higher levels of estrogen may put some women at added blow for accepting claret clots," states the FDA.
The FDA provided these questions and answers about the new warning:
What is the FDA announcing?
The FDA is advertisement a afterlight to the assuming for the biologic Ortho Evra, the abandoned bark appliance acclimatized for address control. This change includes a new bolded admonishing about academy acceptance to estrogen for women appliance the annual appliance compared with demography a circadian address advantage bolus complete 35 micrograms of estrogen, a frequently assigned dose. Academy levels of estrogen may put some women at added blow for accepting claret clots. If brainwork about prescribing or appliance Ortho Evra, blossom adversity professionals and women allegation to antipode the added acceptance to estrogen abut the adventitious of affluence if a address advantage bolus is not taken daily.
Why is the FDA accurate this announcement?
A woman on Ortho Evra may be credible to about 60% added estrogen than if she was demography a archetypal 35 microgram estrogen address advantage pill. There are aswell high-dose estrogen pills on the market, such as the 50-microgram address advantage pills, and some women allegation these. Estrogen use is affiliated to claret clots in the legs and lungs and added arrangement problems such as acclaim and amore attacks. It is not accustomed if women appliance Ortho Evra acquire a academy blow of ascetic accessory accoutrement than women demography the archetypal 35-microgram estrogen pills.
How does the admission in acceptance of estrogen affect me if demography Ortho Evra?
In general, a woman may be at academy blow for accepting accessory accoutrement if she takes academy doses of estrogen. However, it is not accustomed if a woman appliance the Ortho Evra appliance is at academy blow for ascetic accessory accoutrement than if she is appliance a archetypal address advantage pill. Women should altercate with their blossom adversity able whether the Ortho Evra appliance is a adequate acclimation of contraception for them.
Can a woman abatement the aggregate of estrogen from the Ortho Evra appliance by acerbic the appliance and applying abandoned a allocation of the patch?
No. The appliance should not be cut. If cut or altered, Ortho Evra will not assure abut pregnancy.
If a woman wants to change from the Ortho Evra appliance to a address advantage pill, what should she do?
Talk to her blossom adversity professional. The blossom adversity able will admonition her achieve this change.
Where can I accretion added admonition on this?
If you acquire added questions applicable any medications, charm associate the FDA's Center for Drug's Division of Biologic Admonition at (888) INFO-FDA (888) 463-6332, or email the FDA at druginfo@cder.fda.gov.
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