Remeron, (Generic: Mirtazapine), is indicated for the treatment of depression. Signs of depression include depressed mood, weight change, insomnia, fatigue, agitation, suicidal tendencies, feelings of guilt and loss of interest in activities. Remeron comes as a tablet. Approved by the U.S. Food and Drug Administration (FDA) in 2001, Remeron is made by Organon. 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.On December 13, 2006, the FDA announced antidepressants prescribed to young adults are risky. The agency proposed expanding the labels of all antidepressants to include an expanded warning of suicidal thoughts in patients ranging from 18-24 years of age. The newly presented change would expand a warning now on the labels that pertain only to children and adolescents treated with antidepressant drugs. The new label changes would also contain a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment.
The FDA recently completed a bulk evaluation of 372 studies involving approximately 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated risk for suicidal thoughts and behavior among adults 18 to 25 that approaches that seen in children, the FDA said in documents released before their scheduled December 13, 2006 meeting of its psychopharmacologic drugs advisory committee.
FDA Notified Healthcare Professionals Of Reports
In May 2006, GlaxoSmithKline and the FDA cautioned Paxil may raise the risk of suicidal behavior in young adults too and changed the drug’s label to reflect that risk.
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.
Potential side effects of Remeron include, but may not be limited to, drowsiness, dizziness, anxiousness, constipation, upset stomach, vomiting, confusion and dry mouth.
In addition to the aforementioned side effects associated with antidepressants, a new study has linked these drugs to an increased risk of death amongst patients with coronary artery disease. This study, which was conducted at Duke University, analyzed the survival rate of heart disease patients using antidepressants compared with those not using these drugs.
During an average of three years of follow-up, 21.4% of the patients taking antidepressants died compared with 12.5% of those not on antidepressants. After adjusting for demographic factors, cardiac risk factors, scores on the Beck Depression Inventory test, and the presence of other illness, antidepressant use was an independent risk factor for mortality, increasing the risk by 62%.
Researchers do not fully understand why antidepressants increase the risk of mortality in these patients. However their findings are statistically significant and show that these drugs do increase the risk of death in heart disease patients. Current and former heart disease patients should weigh the risks and benefits of antidepressants before using these medications.
Legal Help For Victims Affected By Remeron
If you or a loved one took Remeron and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).