However, According To Another Study Ortho Evra Skin Patch Use Presents No Increased Risk Of Blood Clots
On February 16, 2006 Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson (J&J) unit, announced that some preliminary results from a yet-to-be-published study indicate there is a two-fold increase in the risk of blood clots among users of its Ortho Evra birth control patch when compared to women using a typical birth control pill. At the same time, Ortho-McNeil pointed out the results from a second Ortho Evra study, this one just published on the Web site of the journal Contraception, which showed there was no increased risk of blood clots when Ortho Evra was compared to birth control pills.
As background, in November 2005 the FDA issued a MedWatch Alert telling doctors and patients that the contraceptive patch Ortho Evra might increase the risk of blood clots because the patch contains more estrogen than a typical birth control pill. Specifically, the FDA said women using the Ortho Evra birth control patch are exposed to about 60% more estrogen than if they were taking a birth control pill with the typical 35 micrograms of estrogen. It is the exposure to this higher level of estrogen exposure from the Ortho Evra patch that could significantly increase a woman's risk of developing potentially fatal blood clots.
After the November 2005 FDA alert about Ortho Evra, Ortho-McNeil and J&J said they would conduct additional safety studies on the issue of whether Ortho Evra causes an increased risk of blood clots which, in turn, can produce heart attacks and strokes. The two studies which were announced by the drug companies on February 16, 2006 are part of their effort on that front.
The first Ortho Evra study (not published yet) is being conducted by a unit of Ingenix, which is part of UnitedHealth Group. According to a February 16, 2006 article in The Wall Street Journal (subscription required), by reporter Jennifer Corbett Dooren:
"[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 same data does not show an increase in the risk of heart attacks and strokes, J&J said."
Then there is the second study, published online by the journal Contraception, where researchers examined a medical records database for 200,000 women. Those researchers found that the risk of developing blood clots among Ortho Evra users was about the same as the risk among women using a typical birth control pill.
The heart attack and stroke risk aspect of this second study is still ongoing, Ortho-McNeil said in their February 16 statement, which added "the currently available data do not show an increase in the risk of the combined endpoint of heart attack and stroke."
A day after the Ortho-McNeil / J&J announcement about these Ortho Evra studies, the FDA said further investigation of the issue of whether Ortho Evra causes an increase in blood clots is warranted. As Reuters reported on February 17, 2006, however, Dr. Daniel Shames, director of the FDA's division of reproductive and urologic drug products, made clear that the FDA does not plan to take any action at present based on these two Ortho Evra studies.
As of early 2006, it is estimated that the Ortho Evra birth control patch has been used by more than 5 million women since it was approved by the FDA in 2002.
(Posted by: Tom Lamb)