In June 2004 Serzone was taken off the market in the
United States. The drug was previously taken off the
market in Europe, Australia, New Zealand and Canada.
Serzone is a prescription-only anti-depressant often
used to treat depression, insomnia and anxiety.
It is manufactured by Bristol-Meyers Squibb Company
and was approved by the United States FDA (Food and
Drug Administration) in 1994. Serzone produces
approximately $400 million in annual sales.
Approximately 70% of Serzone users report it to be effective.
In its early stages of treatment, patients may experience
only mild improvement, generally in the areas of sleeplessness
and anxiety. It can take from six to eight weeks before
seeing any signs of stable, significant improvement.
While other SSRIs (Selective Sertonin Reuptake Inhibitors)
can cause weight gain, Serzone has not been proven to do so,
although it can cause an increase in appetite. Other
standard symptoms of most SSRIs, e.g. insomnia, restlessness
and lack of sexual interest, have not been evidenced among
Serzone users. Serzone's most common side effects (usually
occurring within the first one to two weeks) include sleepiness,
dry mouth, nausea, constipation and dizziness.
In spite of Serzone's benefits, it has been found that liver
failure leading to liver transplant, or even death, is 3 to
4 times greater among users than non-users. In December,
2001. the FDA ordered Bristol-Meyers Squibb to issue a 'black
box' warning on all Serzone labels. (A 'black box' warning
is the most serious the FDA requires, and warns both patients
and physicians of the severe side effects of using a particular
drug.) Additionally, the FDA ordered the manufacturer
to include patient inserts with the drug, and write letters
to physicians that further warn of the dangers of liver failure
among Serzone users.
If you or someone you care about has been taking Serzone
and experienced signs of liver failure, a cash award may be
obtainable. Fill out our questionnaire
to obtain a free consultation and find out what your case is worth.
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