Effexor Use in Children

Although Effexor is one of Wyeth Pharmaceutical's top-selling antidepressant drugs, the company has issued a stark warning to doctors that the drug should not be prescribed to children due to an increased risk of suicidal thoughts and aggressive or hostile behaviors evidenced when the drug was given to a study group of children aged 6 to 17 years. The drug was also found to be ineffective against depression in children.

History of Use

• Effexor (venlafaxine, a serotonin and norepinephrine reuptake inhibitor) was introduced in 1993 by Wyeth Pharmaceuticals to treat major depressive disorder (MDD). It has since been approved to treat generalized anxiety disorder, social anxiety disorder, obsessive compulsive disorder (OCD) and panic disorder in adults. By 1997, it was the sixth most prescribed drug in the United States for major depression. As early as 1993, Wyeth executives were warning physicians about the potential risks--including suicidal thoughts, hostility and self-aggressive tendencies--of using Effexor in children aged 6 to 17 years.

Off-Label Use

• According to an article in "USA Today," Effexor is sometimes used "off-label" to treat conditions other than those for which it was originally intended. Examples include migraine prophylaxis, hot-flash relief in menopausal women, and treatment of diabetic neuropathy. Although the practice of prescribing "off-label" is legal, controlled studies do not exist as to the effectiveness and safety of off-label uses of many antidepressants and antipsychotic drugs, so you should seek a second opinion if your doctor suggests using Effexor for purposes other than major depression, generalized anxiety disorder, social anxiety disorder, obsessive compulsive disorder or panic disorder.

Alternatives

• If your child is in need of a medication to treat major depressive disorder, there may be safer alternatives to Effexor. In addition to traditional talk therapy, other types of medications may carry less risks for your child than Effexor. Prozac (fluoxetine hydrochloride)--a selective serotonin reuptake inhibitor (SSRI)--is currently approved for use in treating depressive disorder in children aged 8 years and older. The tricyclic antidepressant clomipramine, as well as Zoloft (sertraline, an SSI) and fluvoxamine (an SSRI), may be used to treat obsessive compulsive disorder in children 10 and older. Another tricyclic antidepressant, imipramine hydrochloride, is used to treat chronic bed-wetting in young children.

Adverse Effects

• The drug Effexor comes with a long list of possible side effects provided by its maker, Wyeth. These include headache, nausea, insomnia, dry mouth, dizziness, sweating, decreased appetite, hypertension, agitation, abnormal dreams, apathy, yawning, constipation, irritable bowel syndrome, fatigue, vertigo, drop in blood pressure, restless legs syndrome, memory loss and increased anxiety, impulsiveness, and shock-like sensations in the brain. According to the drug manufacturer, there is also an increased risk of suicidal thoughts and tendencies, as well as a tendency toward self-harm ideation in children and adolescents taking Effexor.

Withdrawal

• If your child has been taking Effexor, and you have decided to remove her from the drug, you should consult with her doctor about the best method of weaning her from the medication. There can be serious side effects of sudden withdrawal from Effexor. According to the FDA medical products reporting program, symptoms of withdrawal from Effexor may include agitation, anorexia, anxiety, confusion, coordination impairment, diarrhea, dizziness, dry mouth, moodiness, fatigue, headaches, hypomania, insomnia, nausea, nervousness, nightmares, sensory disturbances, somnolence, sweating, tremor, vertigo, and vomiting, among others. Serious side effects may require hospitalization, according to the FDA. Approximately 10 percent of patients in an FDA safety study of Effexor withdrawal were listed as having experienced "serious" side effects during their withdrawal period from the medication.