Sunday, May 21, 2006

Ortho Evra- birth control patch. Is it right for you?

What is Ortho Evra?

Ortho Evra is an adhesive, transdermal birth control patch that is worn on the torso.

How it works?

The patch is intended to release 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol into the bloodstream per 24 hours. It is replaced once a week for three weeks, and no patch is worn during the fourth week during menstruation. The regimen is then repeated.

A brief history:

Ortho Evra was approved by the FDA in November 2001, and over 4 million women have used Ortho Evra since its approval. Ortho Evra continues to be marketed aggressively to both consumers and physicians.

But now, the firm Ortho-McNeil Pharmaceutical, Inc., that manufactures Ortho Evra faces a suit.

According to a web release for reports that
Parker & Waichman, LLP Files Suit Against Ortho-McNeil Pharmaceutical, Inc on behalf of a 33 year old woman and her husband.

The woman was diagnosed with Bilateral Pulmonary Embolism and Deep Venous Thrombosis after using Ortho Evra Birth Control Patch for 2 months.

Ortho-McNeil Pharmaceutical, Inc is a division of Johnson and Johnson Inc. (NYSE:JNJ).

Do you want to know what happened, since the said product is being marketed even now?

The woman suffered a bilateral pulmonary embolism and deep venous thrombosis (DVT) after using Ortho Evra for two months.

Read more below about the web release for
The suit was filed in the United States District Court for the District of New Jersey in Newark, New Jersey. For more information on Ortho Evra please visit or

In May 2005, the affected woman complained of short breath, chest pain. She was taken to the emergency room of Hillside Hospital in Tennessee


Tests revealed a bilateral pulmonary embolism with a large embolus in the right main pulmonary artery and right upper and right lower lobe peripheral infiltrates suspected to be pulmonary infarctions.

Additional tests revealed a deep venous thrombosis of the right popliteal vein extending to the right common femoral vein.

What is pulmonary embolism?

Pulmonary embolism is a sudden blockage in a lung artery, usually due to a blood clot that traveled to the lung from the leg but they can also form in the pelvic vein. Pulmonary thromboembolism can be fatal or may result in pulmonary arterial obstruction, pulmonary obstruction, pulmonary infarction, chronic pulmonary hypertension, dyspenea and tachypnea.


Symptoms may include shortness of breath, difficulty breathing, anxiety, chest pain, fainting and convulsions


The woman was admitted to the hospital’s intensive care unit where she received Coumadin and Lovenox treatment. She was to undergo prolonged treatment with these medications, which may be necessary for the remainder of her life. Treatment may include long term use of anticoagulant medications and/or surgery.

Deep venous thrombosis:

Deep venous thrombosis or DVT is a condition where a blood clot (Thrombus) forms within the deep vein system. The principal veins affected are those in the calf muscles, lower abdomen, groin and inner thigh. The thrombus can interfere with circulation and it may break off and travel through the blood stream, which can cause pulmonary embolism or stroke.

Treatment may include long term use of anticoagulant medications and/or surgery.

Ortho-Mcneil admits:

On November 10, 2005, Ortho McNeil, in conjunction with the FDA, issued a warning about the increased risks of blood clots associated with Ortho Evra.

In the new warning, Ortho-McNeil admitted for the first time that women who use the patch will be exposed to up to 60% more estrogen than they would be exposed to if they were taking a birth control pill with 35 micrograms of estrogen.

The new warnings from the FDA and Ortho-McNeil indicate that the risk of developing blood clots may be significantly higher with the Ortho Evra patch than with oral contraceptives

The patch is only intended to deliver 20 micrograms of estrogen. The FDA's announcement on this warning can be found at

The FDA has logged 9,116 reports of adverse reactions to the patch in a 17 month period, whereas Ortho Tri-Cyclen, a birth control pill, only generated 1,237 adverse reports in a six year period.

During a 12 month period, 44 serious injuries or deaths have been associated with Ortho Evra, whereas only 17 such reports were linked to the birth control pill during a similar time period.

The pattern is further magnified when usage rates are considered: Ortho Tri-Cyclen has six times the number of users as Ortho Evra.

Risk of blood clots:

It is widely understood that increased exposure to estrogen greatly increases the risk of blood clots, which can cause serious injury or death.. Recent reports have indicated that the risk of developing blood clots, pulmonary thromboembolism, heart attack and stroke may be significantly higher with the Ortho Evra patch than with oral contraceptive use.

It is alleged that Ortho-McNeil was aware of the increased medical risks associated with Ortho Evra before the drug was approved and that, once approved, the company failed to adequately warn patients about these risks.

Ortho Evra vs oral contraceptives:

Evidence shows that the risk of blood clots, heart attack and stroke associated with Ortho Evra is significantly higher, than with oral contraceptive pills.
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