The Food and Drug Administration (FDA) announced on November 11, 2005 that the Ortho Evra contraceptive patch exposes millions of women who use the patch to levels of estrogen far higher than most daily birth control pills, putting them at higher risk for blood clots than previously disclosed. The FDA also approved updated labeling for the Ortho Evra contraceptive patch to warn healthcare providers and patients about the increased risk.
The warning, from Johnson & Johnson subsidiary Ortho McNeil, makers of Ortho Evra patch, states that the patch exposes women to 60 percent more estrogen than daily birth control pills, which contain 35 micrograms. Ortho Evra is the first and only skin patch approved for birth control and more than 4 million women have used the patch since it came on the market in 2002. The patch releases ethinyl estradiol, and estrogen hormone, and norelgestromin, a progestin hormone, through the skin into the bloodstream. It only needs to be changed once a week.
The Associated Press in July 2005, reported that, according to FDA records it obtained through a Freedom of Information Act request, women using Ortho Evra in 2004 were three times as likely as women using birth control pills to die or develop nonfatal blood clots. The Associated Press learned that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 in 2004.
Since the FDA estimates that it receives reports of only between 1 percent and 10 percent of the serious adverse drug reactions that actually occur, the death rate for Ortho Evra may be significantly higher.
It is widely known that hormone pills, like oral contraceptives, are associated with an increased risk for abnormal blood clots. However, these events are rare and mainly occur within high-risk groups. Women with cardiovascular risk factors, such as high blood pressure, diabetes, high cholesterol, obesity or a history of severe migraine headaches are at increased risks for blood clots in addition to women older than 35 who smoke. The birth control patch, however, has been prescribed to young women who are generally in good health and at low risk for serious adverse drug reactions.The Ortho-Evra patch, which is available by prescription only, has not yet been pulled off the market. The drug maker says it is launching its own study with input from the FDA to assess the dangers of using the patch. Women who may be using Ortho Evra should contact their physician if any of the following warning signals develop:
(1) Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot
the lung); (2) Pain in the calf (indicating a possible clot in the leg); (3) Crushing chest pain or tightness
in the chest (indicating a possible heart attack); (4) Sudden severe headache or vomiting, dizziness or
fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a
possible stroke); (5) Sudden partial or complete loss of vision (indicating a possible clot in the eye)
Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast); (6) Severe pain
or tenderness in the stomach area (indicating a possibly ruptured liver tumor); (7) Severe problems
with sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe
depression); (8) Jaundice or a yellowing of the skin or eyeballs accompanied frequently by fever,
fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver
ADVERSE EVENTS AND LAWSUITS
Concern about this potentially deadly birth control patch side effect continues to be fueled by recent reports of deaths linked to use of this medication. Reports show that the deaths of at least seventeen young women over the past two years may be related to Ortho Evra patch use. The first fatality publicly blamed on the Ortho Evra patch occurred in April 2005, when a Manhattan student collapsed in a subway station. The autopsy found a blood clot had moved into the woman’s lung; the medical examiner concluded that the clot was a side effect of the birth control patch. FDA records show that seventeen patch users between the ages of 17 and 30 suffered fatal heart attacks, blood clots and possible strokes since August 2002. Accordingly, a number of lawsuits have been filed by or on behalf of women injured by use of the Ortho Evra birth control patch.
Ten women filed suit against Johnson & Johnson ranging in age from 18 to 47 residing in states across the country. All of the women claim they suffered debilitating long-term health problems because of Ortho Evra, including strokes and blood clots. The lawsuit claims Ortho Evra is “defectively designed” and “unreasonably dangerous” and seeks punitive damages against Johnson & Johnson and its subsidiary Ortho McNeil, the birth control patch’s marketer.
One plaintiff, a 19-year old Colorado resident, claims she developed a 10-inch blood clot in her brain that doctors say is a direct result of the patch she used for just three months in 2004. She suffered two strokes and routinely gets migraine headaches.
In December 2005, a lawsuit was commenced in St. Louis on behalf of the estate of a 17 year old who died after using the Ortho Evra birth control patch for 4 months. She left surviving a one-year old child. In January 2006, a 37 year-old California resident filed a lawsuit alleging that Ortho Evra use was responsible for her development of a blood clot in her lungs. In each lawsuit it is alleged that the patch’s maker failed to disclose the serious potential risks associated with this medication, instead stating only that Ortho Evra use carried “similar” risks associated with oral contraceptives, including blood clots, strokes, and heart attacks.
At least forty lawsuits have been filed on behalf of women who have suffered serious injury while using the Ortho Evra birth control patch.