Serzone Facts

Serzone is an anti-depressant. It is often used to treat a specific form of depression. Unfortunately Serzone has been linked to liver failure. According to the manufacturer the rate of liver failure associated with Serzone use is about 3-4 times than greater than non-users.

Bristol-Myers Squibb Co. the maker of Serzone issued a manufacturer's warning on January 9, 2002, telling health care providers that "cases of life-threatening hepatic failure have been reported in patients treated with SERZONE." The warning suggests that numerous patients have experienced or will suffer liver failure.

U.S. psychiatrists first became concerned about the Serzone causing liver failure after the Canadian government issued a warning about the drug in the summer of 2001.

The U.S. FDA told Bristol-Myers Squibb Co. that it must include a "Black Box" warning on all Serzone labels on December 7, 2001.

Such a warning is designed to inform patients about life-threatening liver damage that can occur when using Serzone. The FDA required the warning to advise that patients could suffer from liver failure, leading to death or the need for a liver transplant. A Black Box warning is the strongest type of warning and is designed to let physicians and patients know of serious side effects associated with a particular drug. In addition to warning labels, Serzone patients will also be provided with patient insert warnings. Bristol-Myers Squibb has also been ordered to issue a letter to doctors warning about potential liver failure.

History and Specifics of Serzone: The technical Information

Manufactured by Bristol-Myers Squibb and approved by the U.S. Food and Drug Administration in December 1994. Serzone does about $400 million in annual sales.

A black-box warning will seriously decrease the sales of Serzone. Serzone (generic name: nefazodone hydrochloride) is an antidepressant medication structurally different from other antidepressants (selective serotonin reuptake inhibitors [SSRIs], tricyclics, and monoamine oxidase inhibitors [MAOIs]), but similar to trazodone (Desyrel), Serzone inhibits serotonin reuptake and blocks one type of serotonin receptor.

Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The mechanism of action of nefazodone, as with other antidepressants, is unknown. The effectiveness of nefazodone in long-term use (i.e., for more than 6 to 8 weeks) has not been systemically evaluated in controlled trials.

Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water.

Serzone is supplied as hexagonal tablets containing 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and iron oxides (red and/or yellow) as colorants.

The following information about Serzone was provided by Bristol-Myers Squibb Company. They are now revising this information.

Information to Help You Reach for Relief

The Benefits...

* What is Serzone?

* What does Serzone do?

* With Serzone you can look forward to:

Getting the Best Results...

* What should you expect when taking Serzone?

* Are there any side effects when you take Serzone?

Answers to Some of Your Questions...

* If I miss a dose of Serzone® (nefazodone HCl), what do I do?

* Can I become addicted to Serzone?

* Is it true that antidepressants reduce sexual function?

Inform Your Doctor...

Would you like to be part of the Reach for Relief program?

Usual Serzone dosage

What is Serzone?

Serzone is an antidepressant medication that provides two kinds of relief for people with depression and symptoms of anxiety.

What does Serzone do?

First, Serzone sends a clear signal it's working by alleviating symptoms of anxiety and sleeplessness. So you can start feeling less anxious and get a good night's sleep. Then, as you continue taking your Serzone over the next several weeks, it steadily relieves the underlying depression, and restores your ability to concentrate and enjoy the pleasures of everyday life.

With Serzone you can look forward to:

* Feeling less anxious
* Getting a good night's sleep
* Being able to concentrate better
* Feeling less blue
* Feeling more calm
* Having more interest in pleasurable activities, including sex

What should you expect when taking Serzone?

Serzone is right for the Anxious type of depression. It shouldn't cause nervousness, insomnia, or interfere with your sex life. Many patients who take Serzone as directed by their doctor begin to feel less anxious and sleep better before all of their other depressive symptoms improve. However, it may take up to 4 to 6 weeks before you'll feel the full benefits of Serzone. Please keep in mind that even if you start feeling better, it is important to continue taking Serzone as directed by your doctor. Do not discontinue your treatment without talking to your doctor first.

Are there any side effects when you take Serzone?

Most people taking Serzone tolerate it very well, and, what's more, it's not addictive and won't change your basic personality. However, you may notice some side effects with Serzone. The most commonly reported side effects are dry mouth, sleepiness, nausea, dizziness, constipation, weakness, and lightheadedness. The side effects are usually mild and should pass as your body adjusts to Serzone. In fact, most people who experience side effects are not bothered enough by them to stop taking Serzone.

This information is being revised.

If you or someone you know is taking Serzone and have experienced liver damage you may be entitled to compensation. Contact us for legal consultation

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