Defective Drugs Cases...
Serzone Related Side Affects....

   On January 8th, 2003, Serzone was removed from the market in all European countries because it has been linked to 26 deaths from liver damage. This follows a black box warning issued by the FDA in 2001.

   In December, 2001 The Food and Drug Administration notified Bristol-Myers Squibb Co. that it must include a so-called black-box warning on its label for the antidepressant Serzone advising patients that rare but possibly life-threatening liver failure can occur with use of the drug. A black-box warning label is the most serious warning issued by the Federal Food and Drug Administration.

   The black-box designation refers to a black outline surrounding a section of the label and of the Physicians' Desk Reference, reserved for only the most serious side effects. The agency sent a notice this week to the New York-based company and soon will require Bristol-Myers to warn doctors by letter that patients could suffer severe liver failure that could lead to death or necessitate a liver transplant.

   Serzone is an antidepressant manufactured by Bristol-Myers Squibb; the generic name for Serzone is nefazodone hydrochloride. Serzone was approved by the FDA for use in the United States for the treatment of depression in 1994. Serzone is an anti-depressant in a class of its own in terms of its structure and composition, Serzone shares some characteristics with other serotonin uptake inhibitors like Prozac, Paxil and Zoloft.

Other Names:
Nefazodone

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