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Warning Label on Levitra
FDA approved three drugs for erectile dysfunction are Levitra,
Viagra and Cialis. But the main side
effect of all the three drugs could be mild or transient
vision loss. The affected people developed the condition of
NAION (Non- Arteritic Ischemic Optic Neuropath). NAION is
one of the common reasons of sudden vision loss in aged group
with more than 1000 cases per annum. The main reason behind
this is the function of the ED drugs which blocks the blood
flow to the optic nerve in the inner back of eyes.
A public citizen petitioned the Food
and Drug Administration (FDA) to require a black box warning
on the ED drugs Viagra, Cialis and Levitra for alerting the
user about the risk of NAION. Some drug maker put the warning
label on the drug but it's not prominently displayed on the
label. Clear and bold warning label was demanded by this consumer
group. The maximum numbers of victims of NAION were consumers
of Viagra. The public citizen group also petitioned the US
Food and Drug Administration to add black box warning to the
labels of Levitra, Cialis and Viagra.
In July 2005, FDA ordered the labeling of warning on the three impotence drugs. The other step taken by FDA advised the drug users to stop taking the pills and to consult the doctor if they experience sudden or mild vision loss and to consult a doctor if they already had suffered from vision loss.
Viagra accounts for more cases of blindness than Levitra and Cialis. Public citizen got the data from FDA's Adverse Event Report and analyzed some result. Public citizen group regularly urges FDA to improve the warning label of ED drugs so that it can be more visible and drug taker can read it easily.
The public citizen is also analyzing FDA data to compare the people affected by NAION and LIPITOR (Cholesterol drug). The other factors for NAION are diabetes and heart disease which are also the leading reason of impotence. So it may hard to find out for FDA to determine whether ED drugs contribute to NAION or there are other hidden facts as well.
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