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Remeron

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Remeron Side Effects May Lead To Liver Damage Lawsuits

Remeron | Lawsuits, Lawyers | Side Effects: Blood Abnormalities, Bone Marrow Abnormalities, Liver Problems, Suicide, Suicidal Behavior

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).

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FDA Again Warns About Suicidal Thoughts and Behavior Among Young Adults on Antidepressants

May 3, 2007 | NewsInferno.com
The U.S. Food and Drug Administration (FDA) today issued new warnings about suicidal thoughts and behavior related to young adults taking antidepressants, and they have asked drug makers to update their label warnings appropriately. The FDA uses the term “suicidality” to describe what they call suicidal thinking and behavior. The new “black-box” label warnings, the most strident type of warning, would reflect the increased risks of suicidality in young adults, ages 18...

FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

May 2, 2007 | www.fda.gov
The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months). The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older...

FDA plans to expand antidepressant warning

Dec 14, 2006 | Los Angeles Times
A Food and Drug Administration federal panel Wednesday recommended the agency issue its strongest possible warning to alert patients and doctors that antidepressants can increase the risk of suicidal thoughts and behavior in young adults. The panel called for placing the so-called black-box warning on product labels and in medication guides distributed to patients. Following the vote, FDA officials said they intended to expand the warning to include young adults. Since 2004, antidepressants...

Study shows pills raise suicide risk in young adults

Dec 14, 2006 | Washington Post
Widely used antidepressants double the risk of suicidal behavior in young adults, from around three cases per thousand to seven cases per thousand, according to a federal analysis of hundreds of clinical trials. It marks the first time regulators have acknowledged that the drugs can trigger suicidal behavior among patients older than 18.      Officials at the Food and Drug Administration said Wednesday that the higher risk was found in patients between 18 and 25 and that the risk...

FDA may expand antidepressant warning

Dec 13, 2006 | AP
Treatment with antidepressants increases the risk of suicidal thoughts and behavior in patients age 24 and younger, according to proposed changes to the drugs' labels unveiled Wednesday by federal health officials. The proposed changes would expand a warning now on the labels that applies only to children and adolescents treated with the drugs. The Food and Drug Administration put forth its plan to update the drug labels early Wednesday at the start of a meeting of outside advisers convened...

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