On November 10, 2005, Ortho McNeil, a division of Johnson & Johnson, warned millions of women using Ortho Evra that the birth control patch exposes them to significantly higher doses of hormones and may put them at greater risk for blood clots and other serious side effects than previously disclosed. According to the warning, women using Ortho Evra will be exposed to about 60 percent more estrogen than those using typical birth-control pills because hormones from patches get into the bloodstream and are removed from the body differently than those from pills.
This warning comes after the Food and Drug Administration has received twenty-one reports of life-threatening blood clots and other ailments associated with Ortho Evra birth control patch use. The contraceptive patch, manufactured by Ortho-McNeil, has been aggressively marketed to consumers and doctors as a convenient alternative to oral birth control pills. Approximately 4 million women have used the Ortho Evra Patch since it went on sale in 2002. Earlier this year The Associated Press reported that patch users die and suffer blood clots at a rate three times higher than women taking the pill.
Reports show that the deaths of at least seventeen young American women over the past two years may be related to Ortho Evra patch use. The first fatality publicly blamed on the Ortho Evra patch came in April 2005, when a Manhattan fashion student collapsed in a city subway station. An autopsy found a blood clot had moved into the victim's lung, and the medical examiner ruled that the clot was a side effect of the birth control device. FDA records show that seventeen patch users between the ages of 17 and 30 have suffered fatal heart attacks, blood clots and possible strokes since August 2002.
The Ortho Evra patch is linked with an increased risk of DVT (Deep Venous Thrombosis) and PE (Pulmonary Embolism), which can lead to stroke, hemorrhage, heart attack and death. Evidence shows that the risk of blood clots and stroke associated with Ortho Evra is significantly higher than with oral contraceptive pills. The incidence of embolisms and thrombotic injuries in phase III trials of Ortho Evra was six times greater than the incidence of such events in oral contraceptives using the hormone levonorgestral.
The Food and Drug Administration has received 9,116 reports of adverse reactions to the patch in a 17 month period, as compared to 1,237 adverse reports associated with the oral pill Ortho Tri Cyclen over six year period. During a 12 month period, 44 serious injuries or death have been linked to Ortho Evra, whereas only 17 such reports were linked to Ortho Tri-Cylcen in a similar time period. Ortho Tri-Cyclen has six times the number of users as Ortho Evra. Reports that were obtained by the Associated Press under the Freedom of Information Act indicate that in 2004 when 800,000 women were using the Ortho Evra patch, the risk of dying or suffering a survivable blood clot while using the device was roughly three times higher than while using birth control pills. Many of the patch's victims are in their late teens and twenties who are otherwise completely healthy.
Blood clots are a known risk from hormonal birth control because estrogen promotes blood coagulation. But the FDA knew before the patch's introduction to the market that the incidence of nonfatal blood clots was three times higher with the patch than with the Pill. Clots typically form in the legs and can cause serious injury and death if they travel to the heart, lungs or brain.