Milnacipran - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Milnacipran. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS SAVELLA is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on SAVELLA should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SAVELLA is not approved for use in the treatment of major depressive disorder. SAVELLA is not approved for use in pediatric patients [see Indications and Usage , Warnings and Precautions , Use in Specific Populations ]. WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS See full presc
5 WARNINGS AND PRECAUTIONS Suicidality : Monitor for worsening of depressive symptoms and suicide risk .
Serotonin Syndrome : Increased risk when co-administered with other serotonergic agents, but also when taken alone.
If it occurs, discontinue SAVELLA and any other serotonergic agents, and initiate supportive treatment .
Elevated B lood P ressure and H eart R ate : SAVELLA may increase blood pressure and heart rate.
Measure blood pressure and heart rate prior to initiating treatment with SAVELLA and monitor periodically throughout treatment ( 5.3 , 5.4 ).
Seizures : Cases have been reported with SAVELLA therapy.
Prescribe SAVELLA with care in patients with a history of seizure disorder .
Hepatotoxicity : SAVELLA may cause elevations of ALT and AST.
Avoid concomitant use of SAVELLA in patients with substantial alcohol use or chronic liver disease .
Discontinuation : Withdrawal symptoms have been reported in patients when discontinuing treatment with SAVELLA.
A gradual dose reduction is recommended .
Increased Risk of Bleeding : SAVELLA may increase the risk of bleeding events.
Caution patients about the risk of bleeding associated with the concomitant use of SAVELLA and NSAIDs, aspirin, or other drugs that affect coagulation .
History of Dysuria : Male patients with a history of obstructive uropathies may experience higher rates of genitourinary adverse events .
Sexual Dysfunction : SAVELLA use may cause symptoms of sexual dysfunction .
5.1 Suicide Risk SAVELLA is a selective serotonin and norepinephrine re-uptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders.
Patients, both adult and pediatric, with depression or other psychiatric disorders may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking these medications, and this risk may persist until significant remission occurs.
Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.
There has been a long-standing concern, however, that antidepressants, including drugs that inhibit the reuptake of norepinephrine and/or serotonin, may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.
In the placebo-controlled clinical trials of adults with fibromyalgia, among the patients who had a history of depression at treatment initiation, the incidence of suicidal ideation was 0.5% in patients treated with placebo, 0% in patients treated with SAVELLA 100 mg/day, and 1.3% in patients treated with SAVELLA 200 mg/day.
No suicides occurred in the short-term or longer-term (up to 1 year) fibromyalgia trials.
Pooled analyses of short-term placebo-controlled trials of drugs used to treat depression (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders.
Short-term studies did not show an increase in the risk of suicidality with these drugs compared to placebo in adults beyond age 24; there was a reduction in suicidality risk with antidepressants compared to placebo in adults age 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 drugs used to treat depression in over 4400 patients.
The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients.
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