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FDA issues caution for Ortha Evra
Ortha Evra was approved by the FDA in November
of 2001. It was the first skin patch approved
as a form of birth control. Recent reports regarding
the Ortha Evra Birth Control patch have noted
that over 4 million women have used the patch
since it went on sale in 2002. In 2004, the AP
reported that the FDA received reports of 12 deaths
of Ortha Evra users.
In November of 2005, the FDA approved updated
labeling for the Ortha Evra patch to “warn
healthcare providers and patients that this product
exposed women to higher levels of estrogen than
most birth control pills”. The new warning
specifically states that women who use Ortha Evra
are exposed to 60 percent more estrogen in the
blood than if they were taking a typical birth
control pill. This higher level of estrogen is
causing the increased risk of developing blood
clots and other serious side effects.
Ortha Evra patch users are now advised to contact
their physicians if they experience any of the
following:
- Sharp chest pains, coughing of blood or sudden
shortness of breath (suggesting a clot in the
lung)
- Pain in the calf (indicative of a clot in
the leg)
- Crushing chest pain or tightness in the chest
(indicative of a heart attack)
- Sudden severe headaches, vomiting, dizziness,
fainting, disturbances of vision or speech,
weakness, or numbness in an arm or leg (clinical
indicators of a stroke)
- Sudden partial or complete loss of vision
(indicative of a possible clot in the eye)
The blood clots travel throughout the bloodstream
and cause clinical side effects in the area that
they colonize. One of the most serious types of
blood clots is those that begin in the leg and
travel to the lung. This can lead to pulmonary
embolism where an occlusion occurs from the blood
clot traveling to the blood vessels in the lungs.
Pulmonary embolism is an acute and potentially
lethal disorder. It is one of the four most common
causes of death in the United States. The occlusion
to the blood flow in the lungs can lead to lung
collapse, and the ability for the heart to function
is altered. Successful treatment of blood clots
that have landed in the lungs is dependent on
prompt diagnosis and immediate treatment.
A stroke (often referred to as Cerebrovascular
Accident) is the death of a specific portion of
the brain due to insufficient blood supply. The
extent of the clinical manifestations experienced
is dependent upon the blood vessel affected. Blockage
of cerebral vessels by a blood clot causes the
affected tissue to die and swelling of the surrounding
tissue. The effects of a stroke vary and can include;
paralysis on one side of the body, difficult using
and interpreting the symbols of language (aphasia),
the inability to use affected areas for specific
purposes, visual changes or visual loss, and incontinence.
Timely diagnosis is again critical to one’s
ability to recover. Rehabilitation for those who
have had strokes can be long and arduous.
To determine if an individual has had complications
from the patch, a through review of their medical
history would be indicated. An understanding of
their age at time of incident, knowledge of when
they were prescribed the patch along with their
compliance to medical advice for proper use of
the patch is critical. Further understanding of
their social habits such as smoking can give insight
to understand other risk factors that may have
exposed them to the ill effects mentioned above.
Resources used for this article include;
Drug-Inury.com, FDA.gov, Luckmann’s and
Sorsensen’s Medical-Surgical Nursing: A
Pscyhophysiologic Approach
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