Leslie cannot remember who first raised the question of whether Adrianna was on the birth control patch. But the suggestion sent her searching the Internet for answers. She quickly found dozens of other stories like Adrianna’s – of healthy young women on the Ortho Evra transdermal contraceptive patch who mysteriously suffered sometimes fatal heart attacks, strokes or blood clots.

“Why would they prescribe this?” Leslie asked the Boston Globe. The question is even more painful to ask, knowing that that thousands of lawsuits have mounted against Johnson & Johnson, makers of the Ortho Evra patch, by women who have been injured or died after using the patch. Johnson & Johnson has paid $70 million to settle the lawsuits.

The bad press has dropped sales of the patch by 75 percent, but the drug is still approved for use by the Food and Drug Administration. “It’s needlessly dangerous,” says Sidney Wolfe, director of the Health Research Group at Public Citizen, a consumer advocacy organization in Washington, during an interview with UPI.

The birth control patch was marketed to younger women because the weekly patches provide a more convenient alternative to daily birth control pills. However, those patches have been found to deliver far more estrogen than birth control pills, Those higher estrogen levels can double a woman’s risk of blood clots.

SOURCE: Ortho Evra and Blood Clots › Mother of Ortho Evra user asks why her daughter had to die

The B-12 patchs, made by global nutraceticals company VitaSciences, are sold as an alternative to oral supplements and shots. The company has applied for a patent on the patch and mentions on its Web site a clinical study involving six volunteers. Each patch contains 1,000 micrograms of vitamin B-12 and is designed to be worn once a week for no more than 24 hours. The dime-sized patches are worn on the neck behind the earlobe.

The patches deliver nutrients into the circulatory system by absorption through the skin. A special membrane controls the rate at which the nutrients are absorbed, allowing the active ingredient to release at a consistent rate over a period of time.

But can that delivery system be trusted? Other patch-delivery systems have come under scrutiny lately for seeping too much of the active ingredient into the blood stream. Drug maker Johnson & Johnson has settled numerous lawsuits in both the United States and Canada over its contraceptive patch Ortho Evra. The patch was found to leak too much estrogen into the blood stream causing blood clots which led to strokes and even death in some women.

Earlier this year the company’s pain patch, Druagesic fentanyl, was recalled for leaking too much medicine into some people who used them. That overdosing caused addictions and deaths in some users. While the fentanyl patch has been recalled, Ortho Evra is still widely available for use as birth control.

Vitamin B-12 toxicity, or having too much vitamin B-12 in your system, is uncommon but can have serious side effects. Side effects of vitamin B-12 toxicity include diarrhea, feeling of swelling over the entire body, blood clots in the legs and signs of an allergic reaction such as hives or rash; itching; swelling of the lips, mouth or throat; wheezing or other difficulty breathing.

The B-12 patch is still in a testing phase, and there don’t seem to be any reports so far of adverse reactions, but it is important to be aware of possible dangers based on experience from this type of delivery method. Those who suspect vitamin B-12 toxicity should consult a medical professional.

Sources:
VitaSciences
E Med TV

SOURCE: Ortho Evra and Blood Clots › Consumers should use caution with B-12 vitamin 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

Johnson & Johnson

The Ortho Evra patch was originally marketing to young women who were turned off by the notion of taking a once-daily pill for contraception. The patch is replaced after a week. However, the patch was found in some cases to seep too much estrogen into the bloodstream, which can cause serious health problems.

As an emerging pattern of young women suffering from pulmonary embolisms and strokes emerged, health experts began to point fingers at Johnson & Johnson. Despite the settlements in both the U.S. and Canada, the patch is still on the market and doctors are still prescribing it.

Ortho Evra was first approved for marketing and sale in Canada in 2002. Since then, at least 16 cases of blood clots and one heart attack among women who were using the patch have been reported. Two patients died, including a 16-year-old girl, according to Health Canada.

The Canadian lawsuits involve 22 women from Ontario, British Columbia and Quebec; however, anyone else with a valid claim can still come forward and be included in the settlement. The Canadian plaintiffs sought C$400,00 each in compensation and C$20 million in punitive damages.

The lawsuit claims that Johnson & Johnson failed to properly warn patients and doctors that its Ortho Evra contraceptive patch has a higher risk of blood clots, strokes and heart attacks compared to the birth control pill.

An Ontario judge will be asked to end the suit at a hearing March 23.

SOURCE: Ortho Evra and Blood Clots › J&J settles lawsuits with Canadian women harmed by birth control patch

The clinical trails were held in Australia with 40 women testing a number of skin spray formulations to the forearm once a day over 14 days. The formulations contained the proprietary new generation progestin Nestorone combined with either ethinyl estradiol or estradiol as the estrogen. The amount of each of these hormones in the blood was measured once a day and every four hours on day 14.

These were the first trials to test the performance of daily sprays over an extended period of time. Earlier trials tested only single doses of Nestorone MDTS formulations. Trial results showed that formulations containing Nestorone and ethinyl estradiol successfully delivered therapeutic amounts of both hormones across the skin into the blood. All spray formulations were well tolerated with no serious adverse events recorded, according to the drug maker.

The next step is expected to be a Phase 2 dose-ranging clinical trial before conducting Phase 3 global registration trials.

SOURCE: Ortho Evra and Blood Clots › Contraceptive spray touted as safer alternative to pills, patches

However, students may want to weigh their contraception options more closely. Johnson & Johnson, the makers of the Ortho Evra contraceptive patch has been riddled with lawsuits claiming the patches cause serious side effects in young women, such as blood clots and even death. The patches reportedly can leak too much estrogen into the bloodstream causing the serious health problems.

According to reports, several lawsuits against the company have already ended with confidential settlements and Johnson & Johnson has already told plaintiffs attorneys that it is ready to work out settlements with the others it faces.

The Ortho Evra patch was originally marketed to women seeking an alternative to the once-daily birth control pill. However, since its debut there has been an emerging pattern of young women suffering from pulmonary embolisms and strokes.

Johnson & Johnson no longer actively markets the patch, but it is still available and has yet to be pulled from the market despite petitions by consumer group Public Citizen to the FDA to remove the product. The group also claims removal of the patch would have an environmental benefit, as the discarded patches could leak contaminants into the environment after they are disposed of by consumers.

SOURCE: Ortho Evra and Blood Clots › TCU students urged to heed contraception patch warnings

Clinical data show that the Ortho-Evra patch carries greater risks compared to standard contraception in pill form without providing any real benefits. Public Citizen’s petition listed several reasons why the patch should be banned, including:

• Potentially toxic levels of synthetic estrogen, up to 60% more on average
• Greater variability in estrogen levels than standard oral birth control / inconsistent dosages depending on where on the body the patch is applied
• A substantially higher risk of blood clots: studies indicate that Ortho Evra users were twice as likely to develop venuous thrombosis – life-threatening blood clots in the leg that are fatal if they migrate to the lungs
• Higher risk of side effects such as breast discomfort, severe menstrual pain, nausea, and vomiting
• Higher than usual discontinuation rates; chances of women discontinuing usage due to side effects and irritation caused by wearing the patch are estimated at 50%
• The same results as oral birth control but with harsher side effects and greater risks

The consumer group also argues that a ban on the patch would be environmentally sound. Discarded patches, it notes, contain 80% of the original estrogen dose that threaten to leak and contaminate the environment after disposal.

The group concludes that if Ortho Evra were a pill, its side effects and greater risks would not be tolerated by the FDA.

SOURCE: Ortho Evra and Blood Clots › consumer group urges Ortho Evra ban