Directory of Drugs: Mirtazapine (Remeron) facts and information

Children

Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger. Although mirtazapine is prescribed for children, FDA has not approved mirtazapine for use in children.

Adults

Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, FDA began a complete review of all available data to determine whether there is an increased risk of suicidal thinking or behavior in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that adults being treated with antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.

What Is Mirtazapine?

Mirtazapine is a medicine that is used to treat depression.

Who Should Not Take Mirtazapine?

Never take mirtazapine if you are taking another drug used to treat depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking a MAOI in the last 14 days. Taking mirtazapine close in time to an MAOI can result in serious, sometimes fatal, reactions, including:

High body temperature
Coma
Seizures (convulsions)

MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands.

What Are The Risks?

Suicidal Thoughts or Actions: See FDA Alert.
Agranulocytosis. Mirtazapine may cause agranulocytosis, which is a very low number of a type white blood cells that are needed to fight infection. Call your healthcare professional if you get a fever, sore throat, mouth sores, or other signs of infection.
Severe sleepiness causing impaired judgment, thinking, and motor skills: Do not drive a car or operate dangerous machines until you know how mirtazapine affects you.
Dizziness
Increased appetite and weight gain
Increases in cholesterol, triglycerides and liver function tests
Mania: You may become hyperactive, excitable, or elated.
Seizures. You may experience a seizure (convulsion), even if you are not taking mirtazapine close in time with a MAOI.
Sexual problems: You may have problems with impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire).
Do not drink alcohol. Alcohol can increase the impaired judgment, thinking, and motor skills that happen with mirtazapine.
Other side effects include sleepiness, nausea, increased appetite, weight gain, and dizziness
Tell your healthcare professional about all your medical conditions, especially if you have heart problems, kidney or liver problems, mania, or had a heart attack or stroke. Tell your healthcare professional if you are pregnant or plan to become pregnant. Tell your healthcare professional if you are breast-feeding or plan to breast-feed your baby.

Are There Any Interactions With Drugs Or Foods?

Mirtazapine may interact with medicines other than the ones already mentioned in this information sheet, causing serious side effects. Tell your healthcare professional about all the medicines, vitamins, and herbal supplements you take, especially Valium (diazepam) or other anti-anxiety or sleeping medicines.

How Do I Take Mirtazapine?

Mirtazapine is taken by mouth, with or without food, exactly as prescribed by your healthcare professional.
Mirtazapine orally disintegrating tablets will melt on your tongue. Do not break or split mirtazapine orally disintegrating Tablets.

Is There Anything Else I Need To Know?

You can get more information about antidepressants at: http://www.fda.gov/cder/drug/antidepressants/default.htm

FDA Alert [7/2005]: Suicidality in Pediatric and Adult Patients

All patients being treated with any type of antidepressants should be observed closely for clinical worsening and suicidality especially during the first few months of therapy and when the dose is modified.

Pediatrics

FDA has concluded that suicidal thinking or behavior may increase in pediatric patients treated with any type of antidepressant, especially early in treatment. Increases in suicidal thinking or behavior due to drug can be expected in about 1 out of 50 treated pediatric patients. Note that, although mirtazapine is prescribed for pediatric patients, it is not approved by FDA for use in pediatric patients.

Adults

Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, FDA began a complete review of all available data to determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with any type of antidepressant medication. It is expected that this review will require a year or longer to complete. In the meantime, FDA is highlighting that adults being treated with any type of antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.

Recommendations

All patients being treated with any type of antidepressant for any indication should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. For pediatric patients, such observation would generally include at least weekly face-to-face contact with patients or their family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks. Additional contact by telephone may be appropriate between face-to-face visits. Adults whose symptoms worsen while being treated with antidepressant medications, including an increase in suicidal thinking or behavior, should be evaluated by their healthcare professional.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

Data Summary

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4 percent, twice the placebo risk of 2 percent. No suicides occurred in these trials; however, the duration of treatment was limited. Spontaneous post-marketing reports of suicide-related events associated with the use of SSRIs, including suicidal ideation, suicide attempt, self-mutilation and completed suicide have been received. Because these events may also be related to underlying psychiatric illness, definitive evaluation of the effects of SSRIs on suicide related events from post-marketing reports alone is not possible, and the data from controlled clinical trials is more informative.

Although there are no similar comprehensive data linking the use of antidepressant medications and an increased risk of suicidality in adults, FDA has initiated a complete review of all available data. FDA has asked the manufacturers of all marketed antidepressants to identify all placebo-controlled clinical trials conducted in adults in their development programs for their antidepressant products, regardless of the indication studied, and to provide information from these trials to FDA. Manufacturers are being asked to use a similar approach to assembling this information as was used in evaluating the risk of suicidality in placebo-controlled trials in pediatric patients treated with antidepressant medications.

Date created: May 2005, updated May 9, 2007


FDA ALERT [7/2005] – Suicidal Thoughts or Actions in Children and Adults Patients with depression or other mental illnesses often think about or attempt suicide. Closely watch anyone taking antidepressants, especially early in treatment or when the dose is changed. Patients who become irritable or anxious, or have new or increased thoughts of suicide or other changes in mood or behavior (or their care givers) should contact their healthcare professional right away.
*Children* Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger. Although mirtazapine is prescribed for children, FDA has not approved mirtazapine for use in children. *Adults* Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, FDA began a complete review of all available data to determine whether there is an increased risk of suicidal thinking or behavior in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that adults being treated with antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. What Is Mirtazapine? Mirtazapine is a medicine that is used to treat depression. Who Should Not Take Mirtazapine? Never take mirtazapine if you are taking another drug used to treat depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking a MAOI in the last 14 days. Taking mirtazapine close in time to an MAOI can result in serious, sometimes fatal, reactions, including: High body temperature Coma Seizures (convulsions) MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands. What Are The Risks? Suicidal Thoughts or Actions: See FDA Alert. Agranulocytosis. Mirtazapine may cause agranulocytosis, which is a very low number of a type white blood cells that are needed to fight infection. Call your healthcare professional if you get a fever, sore throat, mouth sores, or other signs of infection. Severe sleepiness causing impaired judgment, thinking, and motor skills: Do not drive a car or operate dangerous machines until you know how mirtazapine affects you. Dizziness Increased appetite and weight gain Increases in cholesterol, triglycerides and liver function tests Mania: You may become hyperactive, excitable, or elated. Seizures. You may experience a seizure (convulsion), even if you are not taking mirtazapine close in time with a MAOI. Sexual problems: You may have problems with impotence (erectile dysfunction), abnormal ejaculation, difficulty reaching orgasm, or decreased libido (sexual desire). Do not drink alcohol. Alcohol can increase the impaired judgment, thinking, and motor skills that happen with mirtazapine. Other side effects include sleepiness, nausea, increased appetite, weight gain, and dizziness Tell your healthcare professional about all your medical conditions, especially if you have heart problems, kidney or liver problems, mania, or had a heart attack or stroke. Tell your healthcare professional if you are pregnant or plan to become pregnant. Tell your healthcare professional if you are breast-feeding or plan to breast-feed your baby. Are There Any Interactions With Drugs Or Foods? Mirtazapine may interact with medicines other than the ones already mentioned in this information sheet, causing serious side effects. Tell your healthcare professional about all the medicines, vitamins, and herbal supplements you take, especially Valium (diazepam) or other anti-anxiety or sleeping medicines. How Do I Take Mirtazapine? Mirtazapine is taken by mouth, with or without food, exactly as prescribed by your healthcare professional. Mirtazapine orally disintegrating tablets will melt on your tongue. Do not break or split mirtazapine orally disintegrating Tablets. Is There Anything Else I Need To Know? You can get more information about antidepressants at: http://www.fda.gov/cder/drug/antidepressants/default.htm FDA Alert [7/2005]: Suicidality in Pediatric and Adult Patients All patients being treated with any type of antidepressants should be observed closely for clinical worsening and suicidality especially during the first few months of therapy and when the dose is modified. Pediatrics FDA has concluded that suicidal thinking or behavior may increase in pediatric patients treated with any type of antidepressant, especially early in treatment. Increases in suicidal thinking or behavior due to drug can be expected in about 1 out of 50 treated pediatric patients. Note that, although mirtazapine is prescribed for pediatric patients, it is not approved by FDA for use in pediatric patients. Adults Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, FDA began a complete review of all available data to determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with any type of antidepressant medication. It is expected that this review will require a year or longer to complete. In the meantime, FDA is highlighting that adults being treated with any type of antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. Recommendations All patients being treated with any type of antidepressant for any indication should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. For pediatric patients, such observation would generally include at least weekly face-to-face contact with patients or their family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks. Additional contact by telephone may be appropriate between face-to-face visits. Adults whose symptoms worsen while being treated with antidepressant medications, including an increase in suicidal thinking or behavior, should be evaluated by their healthcare professional. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Data Summary Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4 percent, twice the placebo risk of 2 percent. No suicides occurred in these trials; however, the duration of treatment was limited. Spontaneous post-marketing reports of suicide-related events associated with the use of SSRIs, including suicidal ideation, suicide attempt, self-mutilation and completed suicide have been received. Because these events may also be related to underlying psychiatric illness, definitive evaluation of the effects of SSRIs on suicide related events from post-marketing reports alone is not possible, and the data from controlled clinical trials is more informative. Although there are no similar comprehensive data linking the use of antidepressant medications and an increased risk of suicidality in adults, FDA has initiated a complete review of all available data. FDA has asked the manufacturers of all marketed antidepressants to identify all placebo-controlled clinical trials conducted in adults in their development programs for their antidepressant products, regardless of the indication studied, and to provide information from these trials to FDA. Manufacturers are being asked to use a similar approach to assembling this information as was used in evaluating the risk of suicidality in placebo-controlled trials in pediatric patients treated with antidepressant medications. Date created: May 2005, updated May 9, 2007