Ortho Evra: New Warnings About Being Overweight and Sauna Or Whirlpool Heat
Changes Made In Canada To Prescribing Information For Birth Control Patch Seems Relevant To Ortho Evra Product In U.S.
In November 2006 Health Canada announced the release of new prescribing information for the birth control patch sold by Janssen-Ortho Inc. in Canada, called Evra (norelgestromin and ethinyl estradiol transdermal system), regarding use of this patch by overweight women and its use in any heated environment, such as a sauna or whirlpool. This drug safety information for the patch came in the form of a "Dear Doctor" letter and a public advisory for patients.
While this announcement by Health Canada and Janssen-Ortho Inc. concerns only the Canadian birth control product Evra, it seems from the language used that this November 2006 drug safety alert applies equally to the Ortho Evra patch sold in the U.S.:
The EVRA* transdermal system marketed in Canada contains 6.0 mg norelgestromin (NGMN) and 0.60 mg ethinyl estradiol (EE) and is approved for use in contraception (prevention of pregnancy). ORTHO EVRA® is the formulation of EVRA* marketed in the United States and contains 6.0 mg NGMN and 0.75mg EE. Although EVRA* and ORTHO EVRA® are manufactured differently and therefore contain different total amounts of estrogen, the risk of side effects reported for ORTHO EVRA® is considered to apply equally to the EVRA* formulation available in Canada.
Moreover, the foundation for this November 2006 Evra warning by Health Canada are the two apparently conflicting studies about Ortho Evra -- sold in the U.S. by Ortho-McNeil Pharmaceutical, a Johnson & Johnson (J&J) company -- concerning the critical issue of whether there is any connection between Ortho Evra and serious blood clot side effects:
The results of a recent study indicate that women using the ORTHO EVRA contraceptive patch (the formulation of EVRA marketed in the United States) had an increased risk of blood clots in the legs and lungs compared to women using an oral contraceptive. Another study indicated no difference in the risk of blood clots in the legs and lungs in women using ORTHO EVRA compared to women using an oral contraceptive.
In the end, this November 2006 Health Canada safety alert sets forth two new safety warnings about the Evra birth control patch:
- "Women who are obese are at particularly high risk of blood clots."
- "Due to a theoretical risk of unintentional increase in estrogen exposure from the patch, patients are recommended not to expose the patch area to sources of heat such as sauna or whirlpool bath."
As of January 2007, however, there had been not been any corresponding announcement by the FDA or Ortho-McNeil Pharmaceutical and J&J regarding a similar revision of the label, or package insert, for the Ortho Evra product in the U.S. Such a new Ortho Evra warning seems warranted in order to make American women aware that they are perhaps at an increased of developing serious blood clots if they are overweight or if the birth control patch is exposed to certain heated environments such as saunas and whirlpools.
Read more on our Ortho Evra Information Page >>