EVRA’s product information now includes average daily release rates for norelgestromin (200 micrograms every 24 hours) and ethinyl estradiol (35 micrograms every 24 hours). This information replaces the previously labeled daily delivery rate of norelgestromin (150 micrograms every 24 hours) and ethinyl estradiol (20 micrograms every 24 hours). The term “release rate” has also replaced the prevous term “delivery rate” as a more descriptive term regarding release of hormones from the patch.

The new data was derived by measuring the hormone content that remained in the EVRA patches worn by women for 7 days. The previously labeled delivery rate information was estimated using a different method. The company reports that there has been no change to the way the patch is made, and there is no known impact on the safety and effectiveness of the patch as a result of the new information on the average daily release rate.

In November 2006, Health Canada issued a letter to health care professionals warning of the risk of venous thromboembolism in users of Ortho Evra and expressed that the same warning should apply to EVRA. Studies have found that the patches can leak too much medicine into the blood stream, causing blood clots that can lead to strokes and even death.

To date, more than 500 lawsuits have been filed on behalf of women who suffered blood clots and other serious side effects from taking Ortho Evra. Recently, drug maker Johnson & Johnson settled lawsuits with Canadian women harmed by the birth control patch.

Sources:

Janssen-Ortho, Inc.
Health Canada

SOURCE: Ortho Evra and Blood Clots › Canadian groups issue label change on birth control patch

The Plan First! program is an outreach by the Wayne County Department of Public Health and targets low-income women between the ages of 19 and 44 who are U.S. citizens or qualified legal residents, are not currently pregnant and are not covered by Medicaid or other family planning coverage.

The Plan First! program offers a wide variety of women’s health services such as office visits, pap tests, breast exams, lab tests, medications, treatment of sexually transmitted diseases and sterilization referrals. It also provides women with birth control options such as the pill, the Ortho Evra contraceptive patch, condoms, vaginal contraceptive ring, spermicide, barrier method and natural family planning.

With birth control costing consumers as much as $50 a month, many low income women may choose to go without it and take their chances with an unwanted pregnancy.

“In today’s environment, higher education and a stabilizing career have become even more important to women and families,” said a spokesperson with the health department. “Controlling the timing of a pregnancy is one of the keys to a bright and promising future.”

However, women should carefully consider birth control methods before choosing one that’s right for them. While convenience and personal beliefs weigh heavy on a decision, so should the safety of the product. Birth control pills come with a sight risk of blood clots, but research has shown that the birth control patch, sold under the brandname Ortho Evra, carries a greater risk of serious health problems, such as blood clots that have lead to stroke and even death in young women.

While contraceptive patch maker Johnson & Johnson has shelled out millions to settle lawsuits from women who were injured by the patches both in the United States and Canada, the drug is still available on the market and prescribed to women.

SOURCE: Ortho Evra and Blood Clots › Plan First! offers free health services, birth control

“Another issue is that contraceptive choice isn’t just a clinical decision, it’s a lifestyle one and it should be promoted this way to women much more than it currently is,” says Julie Bentley, Chief Executive of FPA.

Perhaps another reason why women should take a closer look at their birth control method is the potential health risks it may carry. Women simply cannot trust the FDA to ensure the safety of a product. Of particular concern is the Ortho Evra Contraceptive Transdermal Patch. The patch is one of the newer types of birth control targeting younger women who don’t want mess with the hassle of taking a pill everyday.

The patch’s makers, Johnson & Johnson, however, are facing numerous lawsuits from young women or their family members who have suffered serious side effects such as blood clots, strokes and even death. Some of the lawsuits have already been resolved, ending in confidential settlements. Johnson & Johnson says it is ready to work out settlements in the other lawsuits it faces.

Advocacy groups have petitioned the FDA to pull the patches from the marketplace, but the patches are still available and doctors continue to write prescriptions for them.

SOURCE: Ortho Evra and Blood Clots › Women should spend more time weighing risks of birth control options