Remeron / Mirtazapine

Modified on 2009/10/14 21:31 by admin
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, feelings 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.

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

In October 2003, the FDA notified healthcare professionals of reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various 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 Food and Drug Administration issued a Public Health Advisory that provides further cautions to physicians, their patients, and families and caregivers of patients about the need to closely 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.

See your doctor if you have experienced serious health problems after receiving Remeron. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

See Also

  1. Antidepressants & Other Psychiatric Drugs
  2. Balance Problems: Overview
  3. Blood Disorders: Overview
  4. Hallucinations: Overview
  5. Liver Problems
  6. Severe Constipation: Overview
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