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Remeron, also known as mirtazapine, is indicated for the treatment of mental depression. Signs of depression include a depressed mood, weight change, insomnia, fatigue, agitation, suicidal tendencies, and thoughts of guilt and loss of interest in activities. Remeron comes as a tablet to take by mouth once a day. Approved by the U.S. Food and Drug Administration (FDA) in 1996, Remeron is made by Organon.

Possible side effects of Remeron include, but may not be limited to, drowsiness, dizziness, anxiousness, constipation, upset stomach, vomiting, confusion and dry mouth.

Remeron has been connected to several adverse reactions. The Federal Government's Adverse Drug Reactions Advisory Committee has received dozens of reports concerning serious blood and bone marrow abnormalities. Remeron has been linked to liver problems and hallucinations.

The FDA alerted healthcare experts of reports of the incident of suicidality (both suicidal ideation and suicide efforts) in clinical trials for a variety of antidepressant drugs in pediatric patients with major depressive disorder (MDD). FDA has completed a preliminary review of such reports for 8 antidepressant drugs (citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine) studied under the pediatric exclusivity provision, and has determined that additional data and analysis, and also a public discussion of available data, are needed.

In March 2004, the FDA issued a Public Health Advisory that presented further cautions to doctors, their patients, and families and caregivers of patients about the need to carefully monitor both adults and children with depression, especially at the beginning of treatment, or when the doses are changed with either an increase or decrease in the dose.

FDA is asking manufacturers to change the labels of ten drugs to include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the emergence of suicidal ideation, regardless of the cause of such worsening.

The drugs under review include bupropion, citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, escitalopram and venlafaxine. It should be noted that the only drug that has received approval for use in children with major depressive disorder is fluoxetine (Prozac). Several of these drugs are approved for the treatment of obsessive-compulsive disorder in pediatric patients, i.e., sertraline (Zoloft), fluoxetine (Prozac), and fluvoxamine (Luvox). Luvox is not approved as an antidepressant in the United States.