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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.

"Bristol-Meyers Discontinues Serzone"

Drug manufacturer Bristol-Meyers announced Wednesday that it will no longer make or sell Serzone, an antidepressant that has been linked to potentially deadly liver complications and has already been withdrawn in major markets including Europe and Can...

» Read More

"FDA Sued Over Failure to Act on Petition for a Serzone Recall"

Public Citizen has sued the FDA, calling the agency "grossly negligent" for failing to issue a Serzone ban despite having already been taken off the market in Canada and Europe, with sales to end in Australia and New Zealand in May. The consumer watchd...

» Read More

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