The current Ortho Evra warning label has a bolded warning which states that Ortho Evra exposes women to about 60% more estrogen than typical birth control pills. According to the warning label, taking estrogen has been linked to health problems like blood clots, strokes, and heart attacks, which can cause death. In addition, the Ortho Evra warning label states that women who use the birth control patch are more likely to develop life-threatening complications than women who use other contraceptives.

Ortho Evra FDA Warning Changes

Ortho Evra’s warning label has always included a warning about potentially fatal blood clots. However, the original Ortho Evra warning label suggested that Ortho Evra is no more dangerous than birth control pills. In 2006, the FDA required that Ortho Evra’s maker update the warning label to include study findings 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 determined 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 the current Ortho Evra warning label, although birth control pills contain estrogen levels similar to Ortho Evra, Ortho Evra exposes women to about 60% more estrogen than typical birth control pills. Additionally, the warning states that this is possible because 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.

Ortho Evra Blood Clot Warning Signs

Due to the increased health risks listed on the Ortho Evra warning label, it is important that women know the warning signs related to blood clots. Warning signs or symptoms that indicate a possible blood clot include:

  • arm or leg pain
  • swelling in the arms or legs
  • arm or leg discoloration
  • shortness of breath

A blood clot in the brain, or a stroke, is usually followed by warning signs and symptoms such as:

  • weakness
  • visual disturbances
  • speech impairment
  • seizure

If you or a loved one experienced a serious health problem after using Ortho Evra, please contact us today to learn more about your legal rights and options. 

Published November 17, 2011 by