Ortho Evra Patch

Ortha Evra is a transdermal weekly birth control patch that is prescribed to prevent pregnancy by delivering continuous levels of the hormones norelgestromin and ethinyl estradiol (Progestin and estrogen) through the skin and into the bloodstream. In 2001, the FDA approved Ortho Evra, the first transdermal patch approved for birth control.

This weekly application releases hormones to prevent ovulation and pregnancy. Ortho Evra has been aggressively marketed to consumers and doctors as a convenient alternative to oral birth control pills. Approximately four million women have used the Ortho Evra patch since it went on sale in 2002. The Associated Press reported that patch users may die and suffer blood clots at a rate of three times higher than women taking the pill.

On Novermber 10, 2005, manufacturers of the patch 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. In 2008, the FDA modified the prescribing information for the Ortho Evra patch to include the results of a new epidemiology study that found that users of the birth control patch were at a higher risk of developing serious side effects.

Serious side effects may include:

• Sudden numbness or weakness, especially on one side of the body
• Sudden and severe headache, confusion, problems with vision, speech, or balance
• Chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling
• Sudden cough, wheezing, rapid breathing, coughing up blood
• Pain, swelling, warmth, or redness in one or both legs
• A change in the pattern or severity of migraine headaches
• Nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes)
• Swelling in your hands, ankles, or feet
• Breast lumps
• Symptoms of depression (sleep problems, weakness, tired feeling, mood changes)

Less serious side effects may include:

• Mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps
• Breast tenderness or swelling, nipple discharge
• Freckles or darkening of facial skin, increased hair growth, loss of scalp hair
• Changes in weight or appetite
• Problems with contact lenses
• Vaginal itching or discharge
• Changes in menstrual periods, decreased sex drive