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Serzone Warning to  Antidepressant Users

Nefazodone hydrochloride, an antidepressant medication, is sold under the brand name Serzone^®. Serzone is marketed by Bristol-Myers Squibb Company. Its primary mode of action occurs by 'stabilizing' chemical levels in the brain that may otherwise become unbalanced and cause depression. The primary purpose of this antidepressant is to relieve or remove suicidal or death-related thoughts, symptoms of depression (guilt, sadness, or worthlessness), appetite changes or loss of appetite, over-tiredness resulting in too much sleep, insomnia, thoughts of death or suicide, and loss of interest in daily activities.  As a result of the wide-ranging popularity of this drug, it was and continues to be widely prescribed.

However, research has indicated that health-related injuries can be severe. These findings led the United States Food and Drug Administration (FDA), on December 7, 2001, to require the manufacturer to include a warning in its packaging. The FDA required Bristol-Myers Squibb Company to place a warning, referred to as a ' black box warning', on Serzone labels informing patients that life-threatening liver damage can occur with Serzone use. On January 9, 2002, the manufacturer issued that warning.

The warning indicated that "cases of life-threatening hepatic failure have been reported in patients treated with Serzone ." Hepatatic failure is more commonly known as liver failure. Bristol-Myers Squibb Company considers the risk would be acceptably low, however, research proved that its estimation of the liver failure rate due to Serzone use will be "3-4 times the estimated background [levels] of liver failure [considered possible by Bristol-Myers Squibb Company]." Cases of liver failure or damage requiring a liver transplant or resulting in the death of the patient have been reported.

Bristol-Myers Squibb Company has published symptoms of liver damage or failure and advises people with these symptoms to seek medical attention immediately. The following can be symptomatic of liver damage or failure:

• Abdominal and stomach pain
• Appetite loss (lasting several days or longer)
• Severe nausea
• Jaundice, or yellowing of the skin or eyes
• Urine discoloration, darkening

The following are other Serzone-associated symptoms of varying degrees of severity. Please consult a physician if you notice any of these symptoms and you are taking Serzone. Please note that this is not an exhaustive list of potential symptoms.

• Allergic reactions - labored breathing; throat closing; lips, tongue, and face swelling; hives
• Blurred or abnormal vision
• Constipation
• Dizziness, lightheadedness, or drowsiness
• Dry mouth
• Fainting
• Insomnia
• Prolonged, painful, or inappropriate erections (potentially serious condition requiring surgery)
• Ringing in the ears
• Upset stomach

Bristol-Myers Squibb Company has advised that Serzone should not be used in conjunction with certain medications, vitamin supplements, or herbal remedies.  Please visit the manufacturer's web site or read the informational insert that came with the Serzone for more information.

 

NAME	DESCRIPTION
Bristol-Myers Squibb Company	The manufacturer of Serzone®.
Serzone® Product Site	Information about Serzone from Bristol-Myers Squibb.
Revised Serzone Label	Revised Serzone label provided by the Food and Drug Administration (FDA). The document requires Adobe Acrobat.
MedlinePlus - Serzone	Searchable database from the National Library of Medicine. Search for Serzone.
InteliHealth - Serzone Information	Searchable directory from InteliHealth, an Aetna Company.
AMA article about Serzone	American Medical Association (AMA) article regarding Serzone use.
WebMD article about Serzone	WebMD Article regarding Serzone use.
PharmCareNet article about Serzone	PharmCareNet article regarding Serzone use.