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Ortho Evra FDA Alerts

The FDA Alert(s) below may be specifically about Ortho Evra or relate to a group or class of drugs which include Ortho Evra (ethinyl estradiol/norelgestromin).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for ethinyl estradiol/norelgestromin

Ortho Evra Contraceptive Transdermal Patch

Jan 19, 2008

Audience: Reproductive healthcare professionals, patients

[Posted 01/19/2008] FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for VTE.

FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.

[January 18, 2008 - News Release - FDA]

Ortho Evra (norelgestromin/ethinyl estradiol)

Sep 20, 2006

Audience: Gynecologists, other healthcare professionals and consumers

[Posted 09/20/2006] 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. The first study found that the risk of non-fatal venous thromboembolism (VTE) associated with the use of Ortho Evra contraceptive patch is similar to the risk associated with the use of oral contraceptive pills containing 35 micrograms of ethinyl estradiol and norgestimate.The second study found an approximate two-fold increase in the risk of medically verified VTE events in users of Ortho Evra compared to users of norgestimate-containing oral contraceptives containing 35 micrograms of estrogen. Although the results of the two studies differ, the results of the second study support FDA's concerns regarding the potential for Ortho Evra use to increase the risk of blood clots in some women.

Prescribing information for Ortho Evra continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their healthcare professionals about using Ortho Evra versus other contraceptive options.

[September 20, 2006 - Updated Prescribing Information - Ortho-McNeil]
[September 20, 2006 - Drug Information Page - FDA]

Ortho Evra (norelgestromin/ethinyl estradiol transdermal system)

Nov 14, 2005

Audience: Reproductive and other healthcare professionals, and consumers

[Posted 11/14/2005] FDA notified healthcare professionals and patients of revisions to the label for Ortho Evra, a skin patch approved for birth control, that includes a bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 micrograms of estrogen. A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill. Estrogen use is linked to blood clots in the legs and lungs and other clotting problems such as strokes and heart attacks. It is not known if women using Ortho Evra have a higher risk of serious side effects than women taking the typical 35 microgram estrogen pills.

[November 10, 2005 - News Release - FDA]
[November 10, 2005 - Drug Information Page - FDA]

Counterfeit contraceptive patches

Feb 6, 2004

Audience: Reproductive healthcare professionals and consumers

FDA and Johnson and Johnson Co. of Raritan, NJ are warning the public about an overseas internet site selling counterfeit contraceptive patches that contain no active ingredients.The counterfeit contraceptive patches were promoted as Ortho Evra transdermal patches, which are FDA approved, and made by Johnson and Johnson's Ortho-McNeil Pharmaceutical, Inc. subsidiary. These counterfeit patches provide no protection against pregnancy. Consumers who have any of these products should not use them, but instead contact their healthcare providers immediately.

[February 4, 2004 Talk Paper - FDA]

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