Serzone Antidepressant Patient Warning

Very few patients and doctors take the time to read FDA issued label changes warning of serious and deadly Serzone side effects that can occur. Despite a Black Box warning being the strongest FDA warning issued, many doctors even admit not knowing the last time they have seen a drug label. While the FDA has been criticized for not being proactive enough when issuing warnings of possible death and serious side effects, a patient should take responsibility for reading their patient packet inserts and drug labels.

While these informational pamphlets are often hard to read with the fine print and loaded drug information, by educating yourself about the dangers and risks, as well as possible complications to be aware of, you can help prevent death or serious injury from occurring.

 

Serzone Warning

Serzone Black Box Warning

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 Serzone 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such as increased serum AST or serum ALT levels ³ ³ 3 times the upper limit of NORMAL, while on SERZONE should be withdrawn from the drug.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.

If you or a loved one has taken Serzone, learn the warning signs and symptoms of liver damage and contact us to speak with a Serzone Lawyer.


 



Serzone Warnings
The type of liver damage Serzone can cause ranges from asymptomatic reversible increases in serum transaminase to serious cases of liver failure. Liver damage that leads to instances of liver failure resulting in transplant and/or death has been associated to the use of Serzone antidepressant.
What is a Serzone Black Box Warning?
The FDA issues Black Box warnings when a drug is associated to a high risk of serious and deadly side effects. This type of warning is the strongest warning possible. Serzone's manufacturer, Bristol-Myers, was told in December 2001 that their antidepressant drug must include a Black Box to warn patients of the "life-threatening hepatic failure" that had been reported. The "black box" refers to the thick black outline that surrounds the warning.
 
 
 
Serzone Warning