Serzone Anti-Depressant Drug Side Effects

Serzone was FDA approved to be sold in the U.S. market in December 1994 and does approximately $400 million in annual sales. Serzone was seen as an antidepressant with fewer side effects until in December 2001, the FDA required a black box warning to be put on every Serzone label and strengthened the warnings in January.

Serzone Side Effects



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Clinical trials prior to Serzone's FDA approval showed other Serzone side effects. These side effects included, dry mouth, drowsiness, nausea, dizziness, constipation, weakness, lightheadedness, blurred vision, confusion, and abnormal vision. Serzone was also possibly linked to hypomania, a mood swing that ranges from euphoria, racing thoughts, pressured speech, and excessive energy.

The FDA advised Bristol-Myers Squibb Company on December 7, 2001 that their anti-depressant drug Serzone should contain black box warning labels cautioning drug users of the liver damage it has been linked to. Black box warning labels are the most serious warnings the FDA ever issues, which warns, "cases of life-threatening hepatic failure have been reported in patients treated with Serzone." The life-threatening liver failure has been estimated to occur at about 3-4 times the estimated background rate of liver failure. Figures are estimated to be more conservative than the actual number of liver complications that have arisen due to Serzone use because of underreporting.

Cases of Serzone liver failures resulting in death or transplant normally ranged from 2 weeks to 6 months on Serzone therapy. Not all of these Serzone liver failure cases had prior symptoms indicating the resulting problems. There is no way of predicting if Serzone live failure will occur in a patient, but signs of liver dysfunction, including jaundice, anorexia, gastrointestinal complaints, and malaise should be immediately reported to your healthcare provider should any of these Serzone side effects surface.

Serzone FAQ's

What is Serzone?
Serzone is an anti-depressant drug manufactured by Bristol-Myers Squibb Company. More than 7 million Americans have used the once highly popular drug with sales exceeding $100 million. The generic name for Serzone is nefazodone hydrochloride. Serzone differed from SSRI antidepressants because it was associated with minimal weight gain and minimal sexual side effects.

How does Serzone work?
Serzone is meant to treat depression by correcting an imbalance in the amounts of certain natural chemicals, including serotonin and norepinephrine, located in the brain.

What is Serzone used to treat?
Serzone is used to treat clinical depression. Depression is a syndrome characterized by sadness, low self-esteem, loss of pleasure, and sometimes a difficulty functioning. Depression is a cluster of emotional, physical, and behavioral symptoms.

What is a black box warning?
A black box warning on drug labels are the most serious warning issued by the FDA. In December 2001, the FDA notified Serzone antidepressant manufacturer, Bristol-Meyers that it must include a black box warning advising patients that life-threatening Serzone liver failure that has been reported to occur. The black box warning got its name because of the black outline that surrounds the warning section to make it more prominent.

Why did the black box warning get updated again in January 2002?
The FDA and BMS added a black box warning and strengthened the warnings, contraindications, and precautions sections of the Serzone antidepressant label. Serzone liver failure leading to transplant and/or death has continued to be reported

What are common Serzone side effects?
Common Serzone side effects include headache, constipation, dry mouth, drowsiness, insomnia, nausea, vision problems, agitation, dizziness, fatigue, confusion, hypotension, rash or hives, seizures, and lightheadedness. In a study performed on Serzone prior to the marketing of the drug found 16% of the 3,496 patients taking Serzone discontinued their use due to side effects.

Has any legal action been taken for the deadly and serious Serzone side effects?
Individual claims, as well as a recent filing for a Serzone class action, has resulted in response to the adverse side effects antidepressant patients have experienced. For more information on your legal rights regarding Serzone antidepressant drug please contact us.

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