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Ortho-Evra exposes women to dangerous estrogen levels, Public Citizen tells FDA

When Johnson & Johnson received approval from the FDA in November 2001 for Ortho-Evra, a contraceptive patch, the company claimed its product would have two key advantages over existing oral contraceptives:

1) A constant delivery of hormones

2) Improvements in compliance compared to the daily dosing of oral contraceptives

It sounded like a great deal. Women could wear the patch on their skin for seven days before removal. No longer would they have to worry about taking a pill at the same time every day or about the ups and downs of hormone delivery associated with pill use. However, evidence soon emerged showing that the patch wasn’t as great a deal as originally thought.

In 2005, Johnson & Johnson had to make a label change explaining that exposure to estrogen from the patch was a shocking 55 to 60 percent higher than a standard 35 mcg estrogen oral contraceptive. (Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said if the patch had been designed as a pill, it is unlikely to have been approved because of its increased estrogen content.) The company had to change the label yet again in 2006 and 2008 to include studies that revealed an up to two-fold increase in the risk of blood clots in women using the patch compared to standard oral contraceptives.

Public Citizen’s Health Research Group noted these serious problems with the patch as well, which is why it filed a petition with the FDA today stating the patch exposes women to dangerous levels of estrogen, posing a risk of blood clots, and should be removed from the market within six months. You can take action by sending your own comments to the FDA.

Indeed, evidence compiled by Public Citizen reveals that the patch exposes women to:

  • More estrogen and a greater range of estrogen levels;
  • A possible two-fold increase in the risk of blood clots;
  • Increased painful side effects such as breast discomfort, severe menstrual pain, nausea and vomiting;
  • An increased likelihood of discontinued contraceptive use; and
  • No improvement in contraceptive outcomes.

A far cry from a safe, side-effect-free contraceptive. Of course, the patch is still better than no contraception at all, which is why Public Citizen is asking the FDA for a six-month transition period to allow women time to seek a safer, alternative contraception method.

“Women deserve a level of risk at least comparable to or less than the pill for their hormonal contraceptive,” Wolfe said. “The absence of any evidence of a unique benefit combined with the considerable safety problems of high-dose, variable estrogen exposure in Ortho-Evra tips the balance of risks and benefits against its availability as a contraceptive.”

To read the full petition filed with the FDA, go to www.NotMyPatch.org.