| Ortho Evra Birth Control Patch Side Effects Warning. |
| November 16th, 2005 (www.orion-online.net) |
| New York attorney Catherine Heacox of Weitz & Luxenberg said two lawsuits are currently filed against Ortho-McNeil, and she is looking into the AP's research. |
| Many practitioners rely on case reports, Heacox said in a phone interview. |
| The law firm has received inquiries from people claiming they had family members die as a result of the patch and people claiming to have suffered strokes and blood clots. |
| "There have been a number of strokes in very young people," Heacox said. |
| Heacox said she thinks Ortho-McNeil didn't do studies that would have shown the patch's increased risks. |
| Ortho Evra Lawyers sue Patch Maker for Pulmonary Embolism. |
| September 13, 2005 (www.lifesite.com) |
| A 37 year old woman who suffered a pulmonary embolism after using the Ortho Evra contraceptive patch for seven months has filed a lawsuit against the patch’s manufacturer, Ortho-McNeil Pharmaceutical, Inc., a division of Johnson and Johnson Inc. |
| Ortho Evra Lawyers Commence Litigation after Birth Control Patch Alleges Pulmonary Embolism in Patient |
| September 15, 2005 (kaisernetwork.org) |
| The law firm of Parker & Waichman on Wednesday filed a lawsuit on behalf of a woman who suffered a pulmonary embolism after using the Ortho Evra contraceptive patch, alleging that Johnson & Johnson was aware of potentially amplified medical risks associated with the patch and failed to warn patients adequately, the AP/Kansas City Star reports. |
| FDA comments on Ortho Evra Patch Side Effects |
| The Food and Drug Administration today approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients that this product exposes women to higher levels of estrogen than most birth control pills. Ortho Evra was the first skin patch approved for birth control. |
| It is a weekly prescription patch that releases ethinyl estradiol (an estrogen hormone) and norelgestromin (a progestin hormone) through the skin into the blood stream. FDA advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them. |
| Furthermore, women taking or considering using this product should work with their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because Ortho Evra is a patch that is changed once a week, it decreases the chance associated with typical birth control pills that a woman might miss one or more daily doses. |
| The addition of this new warning is a result of FDA's and the manufacturer's analysis directly comparing the levels for estrogen and progestin hormones in users of Ortho Evra with those in a typical birth control pill. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events. |
| The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill containing 35 micrograms of estrogen. However, the maximum amount of estrogen to which women are exposed is about 25% lower with Ortho Evra than they are with typical birth control pills. |
| FDA is continuing to monitor safety reports for the Ortho Evra patch. The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills that contain 35 micrograms of estrogen. |
| The new labeling information is available along with additional information for healthcare providers and consumers online at: |
|
www.fda.gov/cder/drug/infopage/orthoevra/default.htm |
