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July 2005: Newspapers Reveal Ortho Evra Birth Control Patch Is Linked To Blood Clots And Deaths

Associated Press Reports That Safety of Ortho Evra Was Disputed Even Before Approved By FDA In 2001

A July 2005 news article by Associated Press (AP) that was published in numerous newspapers around the country brought to the public's attention the fact that the birth control patch Ortho Evra was linked to an increased risk of blood clots and deaths.

This result, according to the AP article, was because the Ortho Evra birth control patch exposes women to higher levels of estrogen than a typical birth control pill. In turn, the higher levels of estrogen causes an increased risk of developing blood clots in women using the Ortho Evra skin patch.

For this July 2005 AP article, investigative reporters reviewed a collection of adverse drug event reports for Ortho Evra which had been made to the FDA's MedWatch program. The AP's investigation found that 17 of the 23 death cases associated with use of the Ortho Evra birth control patch appeared to be related to the formation of harmful blood clots. The AP article reported that in 2004, alone, 12 deaths of Ortho Evra users were reported to the FDA.

As background, the FDA acknowledges that for any prescription drug approved for use in the U.S., their MedWatch program generally receives reports for only a small percentage -- in the range of 1% to 10% -- of the serious adverse drug reactions that actually occur. So the actual number of deaths due to blood clots in Ortho Evra users is probably much higher than reported by the AP in the summer of 2005.

From the AP's investigative report we learned that the safety of the Ortho Evra birth control patch was in dispute even before it was approved by the FDA in 2001. By examining documents related to FDA reviews of clinical trial results submitted by Ortho-McNeil in support of Ortho-Evra, the AP reporters found that the FDA medical officer reviewing the Ortho Evra application disagreed with Ortho-McNeil about whether or not two cases of blood clots in the lungs of young women participating in early Ortho Evra clinical trials were caused by birth control patch. In relevant part, the FDA medical officer wrote:

"THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S [Ortho-McNeil] ABOVE CONCLUSIONS. The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases in the ... group [emphasis in the original]."

Despite the FDA medical officer's concerns about an increased risk of developing blood clots Ortho Evra was approved by the FDA in November 2001.

It would be four years later -- and only after this July 2005 AP article caused many women and their doctors to wonder where was the FDA on this safety issue -- before new warning language is added to the Ortho Evra label about the increased risk of blood clots due to the heightened levels of estrogen. By this point in time, however, it was estimated that more than 5 million had used the Ortho Evra patch without knowing about this serious safety issue.

To date, Ortho Evra is the only contraceptive product in the form of a skin patch to be approved by the FDA. Due to this distintion, this birth control product is sometimes referred to simply as "The Patch". Ortho Evra is sold by Ortho-McNeil Pharmaceuticals, Inc., which is a subsidiary of Johnson & Johnson.

Read more on our Ortho Evra Information Page >>


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