Side effects
In three large clinical trials involving a total of 3,330 women using the Ortho Evra / Evra patch for up to one year, 12% of users discontinued the patch because of adverse events. The most frequent adverse events leading to patch discontinuation were: nausea and/or vomiting (2.4%), application site reaction (1.9%), breast discomfort, engorgement or pain (1.9%), headache (1.1%), and emotional lability (1.0%).[12]
The most frequent adverse events reported while using the Ortho Evra / Evra patch were: breast discomfort, engorgement or pain (22%), headache (21%), application site reaction (17%), nausea (17%), upper respiratory tract infection (10%), menstrual cramps (10%), and abdominal pain (9%).[12]
Thromboembolic risks
All combined hormonal birth control products have a very small increased risk of serious or fatal thromboembolic events. There is ongoing research into the thromboembolic risks of Ortho Evra as compared to combined oral contraceptive pills. A recent study found that users of the contraceptive patch may have a twofold increased risk for non-fatal venous thromboembolic events compared with women who took a norgestimate-containing oral contraceptive with 35 µg of estrogen.[16][17] However, a different study concluded that the risk of nonfatal venous thromboembolism for the contraceptive patch is similar to the risk for oral contraceptives containing 35 µg of ethinyl estradiol and norgestimate.[18] The contradiction in findings between the two studies is not easily resolved, because the confidence intervals for the studies are overlapping.
In studies with oral contraceptives, the risk for cardiovascular disease (such as thromboembolism) is significantly increased in women over the age of 35 years who also smoke tobacco.[19] Hence, Ortho-Evra's package insert states: "Women who use hormonal contraceptives, including ORTHO EVRA, should be strongly advised not to smoke."
According to the manufacturer, the patches introduce a 60% higher level of estrogen into the bloodstream as compared to oral contraceptives; however, the clinical significance of this difference is unknown.
On November 10, 2005 Ortho McNeil, in conjunction with the FDA, revised the label for Ortho Evra, including a new bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 µg of estrogen, noting that higher levels of estrogen may put some women at increased risk for getting blood clots. The label was again revised in September 2006, and on January 18, 2008, the FDA again updated the label to reflect study results. "The 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."[20]
Lawsuits
The Patch has been associated with strokes and thrombosis and the mechanism for hormone absorption and dissipation from the body's tissues is different from "the pill." Several lawsuits have been instigated over these issues.
A lawsuit filed in Federal Court in New Jersey on September 2, 2005 by a Georgia woman who suffered a pulmonary embolism alleges the company promoted the patch despite knowledge of its health risks, for financial gain, while failing to warn of the risks of blood clots and other injuries.
In November 2005, CBS News aired a story about documents that surfaced in a lawsuit involving a young mother who was paralyzed by a stroke and remained a total invalid, which showed the company had received nearly 500 reports of adverse events between April 2002 and December 2004. During the same time frame, only 61 adverse event reports were filed in connection with all type of birth-control pills. [1]
The parents of a 14-year-old girl from Wisconsin have filed a lawsuit against Johnson & Johnson because they claim that she died from a blood clot that arose from her use of the Patch.[2]