Warnings & Recalls for Serzone
Recall & Black Box Warnings
Before its removal from the market, Serzone was issued a
black box warning due to its risk for causing
serious hepatic damage, particularly liver failure or other irreversible damage. When it was discovered that numerous cases had emerged, Serzonze was voluntarily recalled.
Serzone was also issue this box warning due to the risk of serious, potentially fatal side effects resulting from
interactions with other medications. Patients who are taking Serzone should not take any other antidepressant medications that contain MAOI or SSRI components, as combining these medications can cause coma or death. Patients who have previously taken an MAOI medication should consult their doctor before taking Serzone, as there may be trace elements of this medication remaining in your body.
Serzone Drug Interactions
Patients who are taking Serzone should consult their doctors before taking any of the following medications, as these can interact with Serzone, compromising this medication's effectiveness or causing side effects:
- SSRI or MAOIs
- Triazolam
- Alprazolam
- Carbamazepine
- Terfenadine, cisapride, pimozide, and astemizole
Serzone General Warnings
- Serzone may cause an increased risk for the rare development of suicidality or mania in patients with a medical history of depression or bipolar disorder.
- Patients with a history of liver disease should not use Serzone.
- Do not use alcohol as this can negatively interact with this medication.
- Driving or operating heavy machinery is not advised unless you fully understand how Serzone will affect your reactions.
- Serzone has been issued a Category C pregnancy warning due to the potential risks associated with the fetus. Alert your doctor if you are pregnant, trying to become pregnant, or are breastfeeding.
Serzone Treatment and Use
Serzone | Nefazodone is a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant which was removed from the U.S. market after numerous cases of liver failure, some of which were fatal or required transplant, were connected to Serzone use. Before its removal, Serzone was used in the treatment of depression, and helped prevent the relapse or occurrence of major depressive episodes, which are characterized by:
- persistent depressed mood or loss of interest that interferes with everyday activities
- significant weight (gain or loss) or appetite changes
- difficulty sleeping, insomnia, or fatigue
- unexplained feelings of guilt or worthlessness
- difficulty thinking or concentrating
- suicidal thoughts or attempts
Serzone has also been removed from the pharmaceutical markets in other countries, such as Canada, Europe, and Australia. Generic versions of Serzone | Nefazodone are still available in the U.S.
How does Serzone work?
Although it is not exactly understood how Serzone works, it is thought to restore balance to certain chemicals in the brain that affect mood, such as serotonin and norepinephrine. These chemicals function as neurotransmitters which are reabsorbed by the body; Serzone prevents these chemicals from being reabsorbed by the body and keeps them at a healthy, balanced level.
Why was Serzone recalled?
In May 2004, the emergence of several cases of serious liver failure, some which proved to be fatal, prompted manufacturer Bristol-Myers Squibb to remove Serzone from the market. Patients who used Serzone for a range of 2 weeks to 6 months were found to be the most at-risk for developing more serious liver conditions, such as liver failure resulting in death or organ removal. Before its removal, Serzone was issued a black box warning due to this risk; see the ‘Warnings & Recalls’ tab for more box warning information, and the ‘Side Effects‘ tab for symptoms of liver failure.
If you or someone you know was taking Serzone and has suffered any serious side effects, such as those listed above, contact someone who can help you right away.
