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Precautions and Warnings With Levomilnacipran

There are a number of important precautions and warnings with levomilnacipran to be aware of, including serious side effects that may occur and situations where the medicine should be avoided altogether. Levomilnacipran may cause suicidal thoughts or behavior, bleeding, or seizures in some people. Do not take it if you have certain allergies, have taken an MAOI within the past two weeks, or are currently taking linezolid.


What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking levomilnacipran (Fetzima™) if you have:
Also, let your healthcare provider know if you:
  • Drink alcohol regularly
  • Are pregnant or thinking of becoming pregnant
  • Are breastfeeding.
Make sure to tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Levomilnacipran Precautions and Warnings

Some warnings and precautions to be aware of prior to taking levomilnacipran include the following:
  • Studies have shown that antidepressant medications may increase suicidal thoughts or actions in children, adolescents, and young adults (see Fetzima and Suicide for more information). The risk is probably highest during the first few months of treatment and whenever the dose is changed. However, it should be noted that untreated depression is also associated with suicidal thoughts and actions.

    Let your healthcare provider know immediately if you have thoughts of suicide or dying, worsening depression, or experience any of the following symptoms during levomilnacipran treatment:
    • Feelings of anxiety or panic
    • Being angry, aggressive, hostile, or violent
    • Agitation or irritability
    • Difficulty sleeping
    • Being overly impulsive or wanting to act on dangerous impulses
    • Extreme restlessness
    • An overly inflated sense of happiness or elation
    • Any other unusual changes in your mood or behavior.
  • Before you start levomilnacipran, your healthcare provider will want to make sure you don't have bipolar disorder. Antidepressants could lead to mania in people with this condition. It should be noted that levomilnacipran is not approved for the treatment of bipolar disorder.
  • Like other antidepressants, levomilnacipran has the potential to cause a rare but potentially life-threatening condition known as serotonin syndrome. Serotonin syndrome occurs when there is too much serotonin in the body. Taking levomilnacipran with other medications that affect serotonin can increase your risk for this condition (see Drug Interactions With Levomilnacipran). Contact your healthcare provider immediately if you develop possible symptoms, which could include:
    • Agitation
    • Feeling delirious
    • Confusion
    • Seeing or hearing things that are not real (hallucinations)
    • A fast heartbeat (tachycardia)
    • High or low blood pressure
    • Dizziness
    • Sweating
    • Flushing
    • High body temperature
    • Tremor
    • Stiff or twitching muscles
    • Overactive reflexes
    • Problems with walking or coordination
    • Nausea and vomiting
    • Diarrhea
    • Coma.
  • This medication can cause an increase in blood pressure and heart rate. If you have high blood pressure (known medically as hypertension) or an abnormally fast heart rate, your healthcare provider will make sure these problems are adequately controlled before starting you on levomilnacipran. You will need to have your blood pressure and heart rate checked periodically during treatment.
  • Like most other antidepressants, this medication may increase your risk for bruising and bleeding. Bleeding due to levomilnacipran can include problems such as nosebleeds or more serious abdominal (stomach) or intestinal bleeding. Taking this medication with other products that can cause bleeding, such as aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs), increases this risk even more (see Drug Interactions With Levomilnacipran). Contact your healthcare provider right away if you experience any unusual bruising or bleeding during treatment.
  • Levomilnacipran can make narrow-angle glaucoma worse. Therefore, if you have this condition, you will need to be monitored during treatment. People with uncontrolled narrow-angle glaucoma should not use this medication.
  • This drug can cause problems with urination, including difficulty with starting or maintaining a urine flow or an inability to completely empty the bladder. Let your healthcare provider know if you have any of these problems during treatment.
  • Suddenly stopping levomilnacipran can cause uncomfortable withdrawal-type symptoms known as discontinuation syndrome (see Fetzima Withdrawal). Do not stop taking this medication without first talking to your healthcare provider. If you no longer need to take it, your healthcare provider will most likely reduce your dose gradually to prevent discontinuation syndrome.

    If you develop discontinuation syndrome while stopping this medication, your healthcare provider can slow down how quickly you are being taken off it. Symptoms may include:
    • Low, abnormally high, or unstable mood
    • Irritability
    • Agitation
    • Anxiety
    • Confusion
    • Dizziness
    • Burning or prickling sensations
    • Headache
    • Fatigue
    • Insomnia
    • Ringing in the ears
    • Seizures.
  • Treatment with antidepressants like levomilnacipran can cause low blood sodium levels (hyponatremia). Let your healthcare provider know if you have signs of hyponatremia during treatment, such as:
    • Confusion
    • Problems concentrating
    • Memory problems
    • Headache
    • Unsteadiness or falling
    • Weakness
    • Dizziness or fainting
    • Hallucinations
    • Seizures.
  • Levomilnacipran may affect your ability to perform complex tasks requiring mental and motor skills. Taking it with alcohol can increase this effect. Do not drive or perform activities requiring mental or motor concentration until you know how this medication affects you.
  • Levomilnacipran is a pregnancy Category C medication, which means it may not be safe for use during pregnancy. Talk to your healthcare provider about the risks and benefits of using this medication when pregnant (see Fetzima and Pregnancy).
  • It is unknown if levomilnacipran passes through breast milk. Therefore, if you are breastfeeding or plan to start, talk with your healthcare provider before using this drug (see Fetzima and Breastfeeding).
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