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Warning Added to Ortho Evra Birth Control Patch

The FDA announced a revision to the label for the birth control skin patch Ortho Evra. This change includes a new bolded warning about higher exposure to estrogen for women using the weekly patch compared with taking a daily birth control pill containing 35 micrograms of estrogen, a commonly prescribed dose. Higher levels of estrogen may put some women at increased risk for getting blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. (Medscape)


Prescribing Revisions for Ortho Evra

Ortho-McNeil and FDA notified healthcare professionals and patients about revisions to the prescribing information to inform them of the results of two separate epidemiology studies that evaluated the risk of developing a serious blood clot in women using Ortho Evra compared to women using a different oral contraceptive. Although the results of two studies differ, the results of the second study support FDA's concerns regarding the potential for using Ortho Evra to increase the risk of blood clots in some women. (Drug Guide)


Next Generation Birth Control Patch Now in Development

The next generation of contraceptive patches, one that is designed to deliver low doses of birth control hormones over a seven-day period is now being developed

An important benefit of the contraceptive patch is that it delivers the estrogen and progesterone hormones directly into the bloodstream, slowing the rate at which hormones are delivered, without the peak doses to the liver that the pill entails. The contraceptive patch, which is worn for seven days, is designed especially for women who have a hard time remembering to take a daily pill. Transdermal patches can have different designs but are meant to deliver drugs across the skin using passive diffusion.
(Medical News Today)


Ortho Evra Lawsuits Being Filed

Lawsuits are being filed on behalf of young women who were using the Ortho Evra birth control patch and suffered strokes, heart attacks, deaths, blood clots, pulmonary embolism, and other serious injuries. These types of injuries are very uncommon in young... (Read Article)


Ortho Evra Patch Labeling Updates FAQ

September 20, 2006--Information provided by Johnson & Johnson on Feb. 16, 2006 was based on an interim report from one of the two epidemiological studies. The label is now being updated with the available results from the two studies. These two studies were... (Read Article)


Texas Woman Sues Johnson & Johnson's Ortho Evra Patch

A Texas woman who suffered a miscarriage and developed blood clots after using the Ortho Evra birth control patch has filed a federal lawsuit against Johnson & Johnson. The complaint says the package insert that came with Ortho Evra was misleading and in direct conflict with Johnson & Johnson's own data. According to the prosecuting law offices, the insert suggests the risk of blood clots among Ortho Evra users is equivalent to that of women using other oral contraceptives. (Read Here)


September 2006 « 

 
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