ortho new.jpgOn May 8 Public Citizen, a group founded by Ralph Nader, filed a petition with the FDA to ban Johnson & Johnson’s Ortho-Evra birth control patch. It stated:

Compared to standard 35 microgram estrogen/progestin oral contraceptives, Ortho-Evra results in:

  • 60% more estrogen on average exposure;
  • greater variability in estrogen levels;
  • a possible two-fold increased risk of venous thrombosis (typically, painful blood clots of the leg which can travel to the lungs and cause death);
  • increased risk of side effects such as breast discomfort, severe menstrual pain, nausea, and vomiting;
  • a 50% increased likelihood of [contraceptive] discontinuation;
  • no improvement in contraceptive outcomes.
  • According to PC’s press release

    In 1988, the FDA requested the withdrawal of all oral contraceptives with estrogen levels greater than 50 mcg because of the risk of blood clots and lack of additional contraceptive efficacy. The Ortho-Evra patch contains estrogen equivalent on average to a 56 mcg pill.

    According to LawyersandSettlements.com, May 7, which is currently probing a class action lawsuit:

    Currently, more than 3,000 women and their families in the U.S. are suing Johnson and Johnson, the makers of the Ortho Evra birth control patch, because they have suffered life threatening adverse health effects such as blood clots, heart attacks, and stroke, as a result of using this controversial form of birth control. Some 40 women have died while using it [since it was approved in 2002].

    PC has also petitioned the FDA to ban all third generation oral contraceptives for their increased risk of blood clots.

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