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Serzone Antidepressant Drug

Serzone Defective Products Lawyers

If you need a lawyer’s assistance with a Serzone drug issue  please  contact  our Indiana  Defective Products Lawyer

Serzone Warning to  Antidepressant Users

Indianapolis Defective Product AttorneyNefazodone 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.

Defective Products Lawyers

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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.



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