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Re: Anyone had success on Effexor XR...yes.(long)

Posted by not2late4u on December 30, 2004, at 22:05:24

In reply to Re: Anyone had success on Effexor XR...yes.(long) » FaithT, posted by dancingstar on December 30, 2004, at 13:33:46

Just had to post this from the website. I have to wonder if the prescribers are the ones who are mostly negligent. Renee.

Wyeth wishes to inform you about an update to the prescribing information for EFFEXOR® (venlafaxine HCl) Tablets and EFFEXOR® XR (venlafaxine HCl) Extended-Release Capsules. Please download and review these important safety information updates.
Health Care Professional Letter – June 3, 2004

Health Care Professional Letter – August 22, 2003


EFFEXOR® XR (venlafaxine HCl) is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs). EFFEXOR XR should not be used in combination with an MAOI or within at least 14 days of discontinuing treatment with an MAOI because of potential for serious adverse reactions. Based on the half-life of EFFEXOR XR, at least 7 days should be allowed after stopping EFFEXOR XR before starting an MAOI.

Both adult and pediatric patients with major depressive disorder (MDD) can experience worsening of their depression and/or the emergence of suicidal ideation and behavior, whether or not they are taking antidepressants. Patients treated with antidepressants should be observed closely for clinical worsening and suicidality, especially at the beginning of drug therapy, or at the time of increases or decreases in dose.

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania have been reported in patients taking antidepressants. Discontinuation or modification of therapy should be considered when symptoms are severe, abrupt in onset, or not part of presenting symptoms.

Treatment with venlafaxine is associated with sustained increases in blood pressure (BP) in some patients. Three percent of EFFEXOR XR patients in MDD studies (doses of 75 to 375 mg/day), 0.5% in generalized anxiety disorder (GAD) studies (doses of 37.5 to 225 mg/day), and 1.4% in social anxiety disorder (SAD) studies (doses of 75 to 225 mg/day) had sustained BP elevations. Experience with immediate-release venlafaxine in MDD studies showed that sustained hypertension was dose related, increasing from 3% to 7% at doses of 100 to 300 mg/day, to 13% at doses above 300 mg/day. Regular BP monitoring is recommended.

Abrupt discontinuation or dose reduction has been associated with discontinuation symptoms. Patients should be counseled on possible discontinuation symptoms and monitored while discontinuing the drug; the dose should be tapered gradually. See the Precautions section of the Prescribing Information.

The most common adverse events reported in EFFEXOR XR short-term placebo-controlled MDD, GAD, and/or SAD trials (incidence >10% and >2x that of placebo) were anorexia, asthenia, constipation, dizziness, dry mouth, ejaculation problems, impotence, insomnia, nausea, nervousness, somnolence, and sweating.

As with any psychotropic drug, EFFEXOR XR may impair judgment, thinking, or motor skills; patients should be advised to exercise caution until they have adapted to therapy.

© Copyright 2004, Wyeth Pharmaceuticals Inc.
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