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FDA revises Evra safety labeling due to increased estrogen levels.
FDA revises Evra safety labeling due to increased estrogen levels
Patch may expose users to about 60% more estrogen than 35 mcg pill
Get ready to discuss questions about the safety of the Evra contraceptive patch (Ortho-McNeil Pharmaceutical, Raritan, NJ) now that the Food and Drug Administration (FDA) has revised the transdermal contraceptive's labeling. The labeling change includes an addition to the drug's warning section to note that the patch exposes women to higher levels of estrogen than most birth control pills. Your patients now will be reading the new bolded warning:
"Hormones from patches applied to the skin get into the blood stream and are removed from the body differently than hormones from birth control pills taken by mouth. You will be exposed to about 60% more estrogen if you use Ortho Evra than if you use a typical birth control pill containing 35 mcg estrogen. In general, increased estrogen exposure may increase the risk of side effects. However, it is not known if there are differences in the risk of serious side effects based on the differences between Ortho Evra and a birth control pill containing 35 mcg estrogen. Talk to your health care provider about how this information relates to your use of Ortho Evra."1
The pharmacokinetic profile for the patch differs from that of oral contraceptives in that it has higher steady state concentrations and lower peak concentrations. Since the level of estrogen fluctuates…
- New Prescribing Information Announced for ORTHO EVRA(R) Birth Control Patch.
- Press release article from: PR Newswire November 10, 2005 700+ words
...estrogen if you use ORTHO EVRA(R) than if you use a typical birth control pill containing 35...differences between ORTHO EVRA(R) and a birth control pill containing 35...professional whether ORTHO EVRA(R) is a good method...
- Ortho Evra birth control patch concerns gather steam.
- Newspaper article from: Daily Record (Kansas City, MO) October 3, 2005 700+ words
...directly to women tout Ortho Evra as a safe and effective form of birth control. But an investigative...other hormonal birth control methods and the Ortho Evra label." David...been using the Ortho Evra birth control patch for about...
- Concerns over Ortho Evra birth control patch gather steam.
- Newspaper article from: Lawyers Weekly USA Tooher, Nora Lockwood September 26, 2005 700+ words
...directly to women tout Ortho Evra as a safe and effective form of birth control. But an investigative...other hormonal birth control methods and the Ortho Evra label." David...been using the Ortho Evra birth control patch for about...
- Burg Simpson Files Suit on Behalf of a Colorado Woman Who Suffered a Pulmonary...
- Press release article from: PR Newswire November 16, 2006 700+ words
...Johnson, the makers of the Ortho Evra birth control patch, on behalf of a...thrombosis due to her use of the Ortho Evra birth control patch. At the age of 31...plaintiff began using the Ortho Evra birth control patch in April of 2004...
- Burg Simpson Files Suit on Behalf of a New York Woman Who Suffered a Pulmonary...
- Press release article from: PR Newswire November 29, 2006 700+ words
...Johnson, the makers of the Ortho Evra birth control patch, on behalf of a...embolism due to her use of the Ortho Evra birth control patch. At the age of 21...plaintiff began using the Ortho Evra birth control patch in November of 2003...
- Burg Simpson files suit on behalf of a Colourado woman who suffered a pulmonary...
- News wire article from: Chemical Business Newsbase November 16, 2006 700+ words
...Johnson, the makers of the Ortho Evra birth control patch, on behalf of a...thrombosis due to her use of the Ortho Evra birth control patch. As a direct result...sustained during the use of the Ortho Evra birth control patch. Additionally...
- Contraception study supports convenience, simplicity of Ortho Evra birth...
- News wire article from: Asia Africa Intelligence Wire February 26, 2004 700+ words
...once-a-week birth control patch, Ortho Evra (norelgestromin...women who took a birth control pill, according...differences between Ortho Evra and an oral contraceptive...correct dosing of a birth control method, was significantly...
- Contraception Study Supports Convenience, Simplicity Of ORTHO EVRA(R) Birth...
- Press release article from: PR Newswire February 26, 2004 700+ words
...once-a-week birth control patch, ORTHO EVRA(R) (norelgestromin...women who took a birth control pill, according...prevention of pregnancy. ORTHO EVRA is not for everyone...professional about which birth control method is right...
- 500 Ortho Evra Birth Control Patch Victims Sue Johnson & Johnson.
- Press release article from: PR Newswire September 18, 2006 700+ words
...deaths and injuries caused by the Ortho Evra birth control patch. NEW BRUNSWICK, N...for alleged side effects from Ortho Evra, including blood clots, heart...million prescriptions for the Ortho Evra patch, according to IMS Health...
- Texas women file new Ortho Evra lawsuits; three new injury claims linked to...
- News wire article from: Chemical Business Newsbase December 5, 2006 700+ words
...lawsuits against the makers of the Ortho Evra birth control patch after doctors diagnosed...of blood clots before taking Ortho Evra, all three have been told by...thinners for the rest of her life. Ortho Evra is an adhesive patch that prevents...
Source: HighBeam Research, FDA revises Evra safety labeling due to increased estrogen levels.
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