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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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