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Serzone Side Effects
Information
Very few patients and doctors take the time to read FDA issued label
changes warning of serious and deadly Serzone side
effects that can occur. Despite a Black
Box warning being the strongest FDA warning issued, many doctors
even admit not knowing the last time they have seen a drug label.
While the FDA has been criticized for not being proactive enough
when issuing warnings of possible death and serious side effects,
a patient should take responsibility
for reading their patient packet inserts and drug labels.
While these informational pamphlets
are often hard to read with the fine print and loaded drug information,
by educating
yourself about the dangers and side effects, as well as possible
complications to be aware of, you can help prevent death or serious
side effects injuries from occurring.
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Reporting Adverse Serzone Side Effects
In 1993, the Food and Drug Administration (FDA) announced
a major new program, MedWatch, intended to encourage health professionals
to increase the number of reports they submit to the FDA of adverse
side effects to drugs, medical devices and other FDA regulated products.
While the addition of MedWatch was significant, it still is "not
enough" according to a professor of pharmacology at Georgetown
University. The actual number of reported cases of adverse side
effects has been estimated to be just 1-10% of the real number of
cases. Serzone has had over 109 cases of Serzone side effects of
liver damage reported, but this number is estimated very underreported
as well. Increasing the number or Serzone side effects reports will
benefit patients and practices nationwide by helping save the and
serious injuries from occurring and help the FDA react faster to
potential side effects problems if necessary. FDA offers several
ways for health professionals or consumers to submit MedWatch reports:
- Online -- Go to the MedWatch Website
and follow the instructions for submitting a Serzone side effects
report electronically.
- By mail -- You can print out the form to take to your
doctor and help her or him fill it out with the information concerning
any adverse Serzone side effects which you and your doctor uncover.
To get a copy, call MedWatch at 1-800-332-1088, and one will be
sent by mail or fax. You also can download the software for printing
out the form through MedWatch's
Website.
- By fax -- You can submit a completed form reporting Serzone
side effects to MedWatch's fax number, 1-800-332-0178.
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Dangers of Serzone
Side Effects
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The type of liver
damage Serzone side effects can cause ranges from asymptomatic
reversible increases in serum transaminase to serious cases of
liver failure.Serzone side effects is linked to liver
damage that leads to instances of liver failure resulting
in transplant and/or death. |
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What is a Black Box
Warning?
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The FDA issues Black
Box warnings when a drug is associated to a high risk of serious
and deadly side
effects. This type of warning is the strongest warning possible.
Serzone's manufacturer, Bristol-Myers, was told in December 2001
that their antidepressant drug must include a Black Box to warn
patients of the side effects of "life-threatening hepatic
failure" that had been reported. |
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