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FDA Adds Warning to Serzone

June 23, 2004 — The FDA issued a warning today for the antidepressant Serzone, saying that those who take the drug are at increased risk of liver failure.

New labeling information for Serzone will also include information about the potential for worsening depression and suicidal thoughts.

In March, the FDA issued a warning about the possibility of worsening depression or suicidal thoughts in people, particularly children, who take any of 10 popular antidepressants, especially at the beginning of treatment or when the doses are increased or decreased.

Earlier this week, the FDA and GlaxoSmithKline sent a notice to doctors and patients regarding the antidepressants Paxil and Wellbutrin and their potential for worsening depression. Other similar warnings regarding the other antidepressants are likely to follow in coming days.

The 10 antidepressants are:

  • Prozac (also sold generically as fluoxetine)

  • Zoloft

  • Paxil

  • Luvox

  • Celexa

  • Lexapro

  • Wellbutrin

  • Effexor

  • Serzone

  • Remeron

Serzone’s Unique Risk of Liver Failure

Serzone carries a unique risk of liver failure that is not seen with the other antidepressants. The FDA and the drug’s manufacturer are encouraging doctors to carefully weigh risks and benefits in prescribing Serzone when deciding among alternative treatments available for depression.

Posted by: Dr.Health

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