New Ortho Evra Black Box Warning: Birth Control Patch Can Kill
According to a new black box warning on the Ortho Evra label, Ortho Evra exposes women to about 60% more estrogen than typical birth control pills. Taking estrogen has been linked to health problems like blood clots, strokes, and heart attacks, which can be fatal. As a result, the current Ortho Evra warning label also states that women who use the birth control patch are at a higher risk of developing life-threatening complications than women who use other contraceptives.
Although birth control pills contain estrogen levels similar to Ortho Evra, estrogen from the Ortho Evra patch absorbs directly into the blood stream whereas estrogen from the pill is digested in the stomach before being absorbed into the blood stream. When a birth control pill is digested, about half of the estrogen contained in the pill is lost before making it into the blood stream.
While Ortho Evra’s warning label has always included a warning about potentially fatal blood clots, the original Ortho Evra warning label suggested that Ortho Evra is no more dangerous than birth control pills. In 2006, the FDA required Ortho Evra’s maker to update the warning label to include study findings with mixed results suggesting that Ortho Evra might be more dangerous than birth control pills.
The most current Ortho Evra warning label reflects findings from a new Ortho Evra study in 2008. The new Ortho Evra study proved that Ortho Evra users are actually more likely to suffer from a blood clot than women who use birth control pills. According to the study, the higher estrogen levels in Ortho Evra make the patch more dangerous than birth control pills.
According to adverse event reports received by the FDA, Ortho Evra may be responsible for the deaths of at least 23 women, 17 of which were caused by blood clots. The first recorded death linked to Ortho Evra occurred in 2004. Zakiya Kennedy, an 18-year-old college student, collapsed while waiting for the subway in New York City. She was rushed to the hospital but died on the way there. Her death was initially a mystery, but an autopsy later revealed that Zakiya died from a pulmonary embolism, which is a blood clot in the lungs. The medical examiner stated that Ortho Evra was to blame for the young woman’s death.
Before long, it emerged that Zakiya Kennedy’s death was not an isolated event. Although blood clots in women under 39 years old are extremely rare, many young women have developed blood clots after using Ortho Evra. For example, lawsuits against Ortho Evra’s manufacturer, Johnson & Johnson, allege that two women developed pulmonary embolisms after using the Ortho Evra patch for only 7 months.
If you or a loved one has suffered from blood clots, stroke, heart attack, deep vein thrombosis, pulmonary embolism, or any other serious injury associated Ortho Evra, you may be eligible for compensation and should contact one of our Ortho Evra attorneys for a free and confidential case review.