February 2006: Ortho Evra Blood Clot Risk Is Double That Of An Oral Contraceptive
Conflicting Study Shows The Patch Presents No Increased Risk Of Blood Clots
Ortho-McNeil Pharmaceutical, Inc., a subsidiary of Johnson & Johnson (J&J), announced on February 16, 2006 that early results from an Ortho Evra safety study indicate an increased risk of blood clots among users of its Ortho Evra birth control patch which is double that of women taking a typical birth control pill. The drug companies said that preliminary data from a second Ortho Evra study, however, shows no increased risk of blood clots associated with the use Ortho Evra, commonly known as "The Patch" among women and their doctors.
Several months earlier, in November 2005, the FDA issued a press release for the contraceptive patch Ortho Evra which addressed the possibility of an increased risk of blood clots caused by the contraceptive patch. According to the FDA, the Ortho Evra birth control patch exposes a woman to about 60% more estrogen than if she was using a birth control pill with the typical 35 micrograms of estrogen. The higher level of estrogen exposure from the Ortho Evra patch could increase a woman's risk of developing potentially fatal blood clots, the FDA said.
Following the November 2005 FDA press release about Ortho Evra, Ortho-McNeil and J&J vowed to produce results of additional, ongoing safety studies. In particular, the drug companies said these studies should shed some light on the issue of whether Ortho Evra increases the risk of developing harmful blood clots. Apparently, the two studies which were announced on February 16, 2006 are part of this effort to determine whether or not Ortho Evra causes blood clots, which can result in pulmonary embolisms, heart attacks, and strokes.
The Ortho Evra study which tentatively shows that the Ortho Evra birth control patch causes a two-fold increased risk of blood clots is not published yet. A February 16, 2006 article in The Wall Street Journal about the early safety study results stated: "[This Ortho Evra study] showed a two-fold increase in the risk of blood clots, or venous thromboembolic events, compared to women on a regular birth control pill."
The other Ortho Evra study has been published online by the journal Contraception. There, researchers examined a medical database covering 200,000 women to determine whether the risk of developing blood clots was any different among Ortho Evra users and women using a typical birth control pill. At this point in their analysis, according to Ortho-McNeil and J&J, those researchers have found no such difference.
Responding to media inquiries the day after the Ortho-McNeil / J&J announcement about the Ortho Evra studies, Dr. Daniel Shames, director of the FDA's division of reproductive and urologic drug products, said that the FDA would not take any immediate action. Due to the conflicting results of the two studies, the FDA has said that there should be further research concerning the issue of whether Ortho Evra causes an increased risk of blood clots.
The drug safety issues regarding the birth control patch Ortho Evra first came to public's attention when an Associated Press (AP) article about Ortho Evra which was published in numerous newspapers during July 2005 revealed there had been reports of harmful blot clots associated with the patch even before it was approved by the FDA in 2001.
By the end of 2005 an estimated 5 million women had used the Ortho Evra birth control patch.
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