SERZONE WARNING

According to a report published in the Wall Street Journal, about one person in 250,000 to 300,000 taking Serzone will suffer liver failure.

A number of U.S. psychiatrists became concerned about the Serzone liver failure problem following the Canadian government issued Serzone warning on June 20, 2001.


A company spokeswoman at Bristol-Myers was asked why Serzone warnings were sent to Canada but not to American physicians warning of the possible fatal liver damage Serzone can cause. The spokeswoman, Tracy Fury, responded that, "We didn't' think it was necessary in the U.S. because what happened in Canada was specific to Canada."


Serzone Side Effects Warnings

  • Skin
    jaundice
    and yellow eyes
  • Bruising
  • Swollen stomach
  • Itching
  • Loss of
    weight and appetite/
    weak
    muscles
  • Pale or black stools/dark urine
  • Tiredness/
    loss of con-centration/ confusion/ personality changes
  • Problems
    with
    sleeping

Serzone Black Box Warning

Bristol-Myers Squibb was told by the FDA on December 7, 2001 to include a Black Box warning on all Serzone antidepressant labels to inform patients of the serious risk of life threatening Serzone liver damages that had been surfacing. A Black Box warning is the strongest type of warning that the FDA can require in a drug's labeling. The Serzone label warning change required by the FDA also had to include a warning that liver failure can result in death or the need for a liver transplant. Bristol-Myers had to send letters warning doctors of the potential Serzone liver failure that could occur when administering the antidepressant medication.

Again, on January 9, 2002, the Serzone warning label was revised when the FDA and BMS added a Black Box Warning and strengthened the WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS sections of the label for Serzone. Rare cases of Serzone liver failure leading to transplant and/or death in patients have been reported. A new Patient Package Insert is also provided in the product packaging.

Serzone Black Box Warning

SERZONE WARNING

Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE. The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 - 300,000 patient-years of SERZONE treatment. The total patient-years is a summation of each patient's duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc. (See WARNINGS).

Ordinarily, treatment with SERZONE should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however baseline abnormalities can complicate patient monitoring.

Patients should be advised to be alert for warning signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur.

SERZONE should be discontinued if clinical warning signs or symptoms suggest liver failure (see PRECAUTIONS: Information for Patients). Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels³ ³ 3 times the upper limit of NORMAL, while on SERZONE should be withdrawn from the drug. These patients should be presumed to be at increased risk for liver injury if SERZONE is reintroduced. Accordingly, such patients should not be considered for re-treatment.


www.fda.gov

View the Full Revised Serzone Label

View the Serzone Patient Packet Insert

 


:Quick Serzone Warning Guide:

Brand name: Serzone

Generic name: nefazodone HCL tablets

How Serzone is administered: Serzone comes in the form of tablets and are taken orally. They come in five dosages: 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg.

What to do if still taking Serzone: If you are still taking Serzone antidepressant drug you are advised to check for warning signs and immediately talk to your doctor about the best options to discontinue the use of the drug that has been linked to dangerous cases of Serzone liver damage.

Contact us to learn about Serzone warning signs and symptoms and your legal rights.

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