NC Serzone Lawsuit
The FDA has issued a warning that cases of life-threatening hepatic failure have been reported in patients using nefazodone hydrochloride (Serzone), a treatment for depression. Over 109 cases of serious liver injuries allegedly associated with Serzone have been reported. In at least 23 cases, Serzone users experienced liver failure and 16 underwent a liver transplant and/or died. Bristol-Myers Squibb, the manufacturer, admits that liver failure rates are 3-4 times greater for Serzone users than non-users. The FDA estimates that the reported rate of liver failure in Serzone patients who used the drug for at least one year is about one case in every 250,000 to 300,000.
Pursuant to the FDA’s directives, Bristol-Myers Squibb has now updated its warnings to both consumers and healthcare practitioners. Patients taking Serzone should be advised to report signs and symptoms of liver dysfunction such as jaundice, anorexia, or gastrointestinal complaints to their physician immediately. If they develop evidence of hepatocellular injury, such as increased serum aspartate aminotrasferase or serum alanine at levels three times or higher than the upper limit of normal, they should be withdrawn from the drug and should not be considered for re-treatment.
Serzone was approved by the FDA for use in the United States for the treatment of depression in 1994. An anti-depressant in a class of its own in terms of its structure and composition, Serzone shares some characteristics with other serotonin uptake inhibitors like Prozac, Paxil and Zoloft. Serzone generates annual sales of $400 million for Bristol-Myers.
We are investigating reports that Bristol-Myers Squibb failed to warn users of a known danger that the drug could cause life-threatening liver damage. For further information on the continuing investigation into the failure of Bristol-Myers Squibb to warn users of the dangers of Serzone, or to discuss your rights as a user of the drug (whether or not you have suffered ill effects), please call us toll free at 888-733-3572 or (800) 811-9495.
Frequently Asked Questions
Serzone was approved by the FDA for use in the United States for the treatment of depression in 1994. An anti-depressant in a class of its own in terms of its structure and composition, Serzone shares some characteristics with other serotonin uptake inhibitors like Prozac, Paxil and Zoloft. It is used to relieve feelings of sadness, worthlessness, or guilt; other symptoms of depression such as loss of interest in daily activities; changes in appetite; tiredness; sleeping too much; insomnia; and thoughts of death or suicide. The drug Serzone generates annual sales of $400 million for its manufacturer, Bristol-Myers Squibb. On May 19th, 2004, Bristol-Myers Squibb announced that due to declining sales, Serzone will no longer be sold in the U.S. after June 14th, 2004. This action does not affect sales of generic versions of Serzone (nefazodone).
In rare cases, treatment with Serzone has been associated with serious liver problems, sometimes resulting in liver transplants or death. Contact your doctor immediately if you experience early signs of liver problems such as: yellowing of the skin or eyes; unusually dark urine; loss of appetite that lasts several days or longer; severe nausea; or stomach pain. Also, do not take Serzone if you have taken a monoamine oxidase inhibitor (MAOI) in the last 14 days, or if you are pregnant or breastfeeding.
The following are uncommon, but serious side effects. If you experience any of these, stop taking Serzone and seek emergency medical attention:
- An allergic reaction (difficulty breathing, closing of your throat; swelling of your lips, tongue, or face; or hives)
- Prolonged, painful, or inappropriate erections (this could lead to a serious condition requiring surgery)
Other, less serious side effects may be more likely to occur. Continue to take Serzone and talk to your doctor when it is convenient if you experience:
- Dizziness, lightheadedness, or drowsiness
- Upset stomach
- Dry mouth
- Blurred or abnormal vision
A major depressive episode usually interferes with daily functions for at least two weeks. Tell your doctor if you have had any of the following symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or thoughts of suicide.
It is more popular. Serzone is chemically different from selective serotonin reuptake inhibitor (SSRI) and monoamine oxidase inhibitor (MAOI) antidepressants. It inhibits the uptake of serotonin and norepinephrine and blocks one type of serotonin receptor. It is thought that this blocking effect greatly decreases the insomnia, weight gain and lack of sexual interest common in patients taking other antidepressants.
A liver function test can detect liver injury.
Individual claims, as well as a recent filing for a Serzone class action, have 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 Younce, Vtipil, Baznik & Banks, P.A.
Cases of life-threatening liver failure have been reported in patients treated with Serzone. When liver failure occurs, a liver transplant may be indicated to prevent death.