Fetzima Warnings and Precautions
People who have kidney disease, seizures, or bipolar disorder may not be able to safely use Fetzima. There are also some safety precautions for people who have bleeding problems, as well as warnings for those who have difficulty urinating. Some people may also have an increased risk for developing problems, such as allergic reactions, thoughts of suicide, and other dangerous complications.
What Should I Tell My Healthcare Provider?
You should talk with your healthcare provider prior to taking Fetzima™ (levomilnacipran) if you have:
- Kidney disease, such as kidney failure (renal failure)
- High blood pressure (hypertension)
- A fast heart rate
- Heart problems
- Ever had a seizure
- Bipolar disorder or have a family member with bipolar disorder
- Ever had an abnormally high mood (mania)
- Had thoughts of suicide or of harming yourself
- Problems urinating
- An enlarged prostate
- Low blood sodium levels (hyponatremia)
- Ever had bleeding problems
- Any allergies, including to foods, dyes, or preservatives.
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 Precautions and Warnings for Fetzima
Some warnings and precautions to be aware of prior to taking Fetzima 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. 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 Fetzima 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 Fetzima, your healthcare provider will want to make sure you don't have bipolar disorder. Antidepressants could lead to mania in people with bipolar disorder. It should be noted that Fetzima is not approved for the treatment of this condition.
- Like other antidepressants, Fetzima 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 Fetzima with other medications that affect serotonin can increase your risk for this condition (see Fetzima Drug Interactions). Contact your healthcare provider immediately if you develop possible symptoms, which could include:
- Feeling delirious
- Seeing or hearing things that are not real (hallucinations)
- A fast heartbeat (tachycardia)
- High or low blood pressure
- High body temperature
- Stiff or twitching muscles
- Overactive reflexes
- Problems with walking or coordination
- Nausea and vomiting
- This medications 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 Fetzima. 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 Fetzima 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 Fetzima Drug Interactions). Contact your healthcare provider right away if you experience any unusual bruising or bleeding during treatment.
- Fetzima can make narrow-angle glaucoma worse. Therefore, if you have this condition, it will need to be monitored during treatment. People with uncontrolled narrow-angle glaucoma should not use this drug.
- This medication 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.
- People with seizure disorders should be treated cautiously with this medication, as it may increase the risk for seizures.
- Suddenly stopping Fetzima 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 Fetizma, your healthcare provider can slow down how quickly you are being taken off the drug. Symptoms may include:
- Treatment with antidepressants like Fetzima can cause low blood sodium levels (hyponatremia). Let your healthcare provider know if you have signs of hyponatremia during treatment, such as:
- Problems concentrating
- Memory problems
- Unsteadiness or falling
- Dizziness or fainting
- Fetzima 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.
- This medicine 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 Fetzima passes through breast milk. Therefore, if you are breastfeeding or plan to start, talk with your healthcare provider before using this medication (see Fetzima and Breastfeeding).