Effexor / Venlafaxine Hydrochloride

Modified on 2009/10/14 21:53 by admin
Updated September 2007-  Effexor, also known as Venlafaxine Hydrochloride, is prescribed for the treatment of severe mental depression. The drug is also used to treat certain anxiety disorders and to relieve the symptoms of anxiety. Candidates for Effexor use often experience suicidal thoughts, difficulty concentrating, fatigue, loss of appetite, and feelings of guilt or worthlessness. The Food and Drug Administration (FDA) approved Effexor, made by the pharmaceutical company Wyeth, in 1993.

Adverse reactions, sometimes fatal, have been reported in patients who have used Effexor in combination with MAO inhibitors, a type of antidepressant drug that increases the brain's concentration of monoamines, organic substituents functionally important in neural transmission. Some patients who have taken Effexor after recently discontinuing use of a MAO inhibitor have suffered from tremors, nausea, hyperthermia, dizziness and seizures.

Other side effects associated with Effexor use include, but may not be limited to, anxiety, constipation, dry mouth, itching, loss of appetite, loss of strength and weight loss. In rare cases, patients have attempted suicide while using Effexor. Former Effexor users have also complained of severe and prolonged withdrawal symptoms, including increased hostility. Effexor and tardive dyskinesia have also been linked.

In August 2003, Wyeth sent a warning letter to physicians notifying them that Effexor may be linked to suicidal behavior.

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. In 2007, the Institute for Safe Medication Practices and the Division of Public Health Sciences, Wake Forest University School of Medicine, conducted a longitudinal Adverse Events Reporting System Review of the U.S. FDA's most dangerous drugs. The study found Effexor to be one of the most dangerous drugs on the market with one of the highest numbers of adverse drug event reports.  Effexor was the fifteenth most dangerous drug, according to the FDA reports.  Over the eight years of the study, effexor was found to have been involved in over 3,600 events resulting in disability or serious incidents requiring medical treatment.

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.

FDA and Wyeth Pharmaceuticals notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of Effexor labeling to alert healthcare providers of two important safety issues.

Neonates exposed to Effexor, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery.

Patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications. The warning recommends patients being treated with antidepressants be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

See your doctor if you have experienced an adverse reaction after taking Effexor. 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.

Attorneys associated with InjuryBoard.com will evaluate your case free of charge. In addition, you will not pay any fees or costs unless your attorney recovers money for you. Please click on the free Ask An Attorney button to take advantage of this valuable service.

See Also

  1. Antidepressants & Other Psychiatric Drugs
  2. Anxiety Disorders & Panic Attacks: Overview
  3. Balance Problems: Overview
  4. Nausea: Overview
  5. Seizures: Overview
  6. Severe Constipation: Overview
  7. Tardive Dyskinesia
  8. Tremors: Overview
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