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Drug Safety Alert * The BirthControl Patch

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posted on Dec, 7 2006 @ 11:03 PM
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On November 23, 2006
Health Canada released a drug safety alert

No Similar Changes To Ortho Evra Label
In U.S. As Of Early December 2006

The Ortho Evra patch - Marketed in Canada as
The EVRA* transdermal system
Canada started by addressing the situation
which arose in September 2006 when we learned about
two conflicting studies about Ortho Evra concerning
whether there is any connection between Ortho Evra
and serious blood clot side effects.

There are two new safety warnings about
the Evra birth control patch set forth in this
November 2006 Health Canada safety alert.

1)
"Women who are obese are at particularly high risk of
blood clots."
2)
"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 December 3, 2006, however,
no corresponding warning about being overweight
nor the sauna and whirlpool heat exposure had been issued by
Ortho-McNeil Pharmaceutical -- a Johnson & Johnson (J&J) company --
for their Ortho Evra product in the U.S.

Not to expose the patch area to sources of HEAT




 
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