Jane S. Ricciuti, RPh, MS

Disclosures

July 13, 2004

In This Article

Antidepressants

Effexor and Effexor XR
(venlafaxine) Tablets

Manufacturer: Wyeth

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 5/13/04)

New Warnings, Precautions: Revisions to the WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of Effexor (venlafaxine) labeling have occurred to highlight 2 important safety considerations:

  1. Neonates exposed to venlafaxine, 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.

  2. 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.

Healthcare providers are urged to read all changes in the product labeling.

Reference

Effexor and Effexor XR (venlafaxine) Tablets

Medscape DrugInfo

Effexor and Effexor XR (venlafaxine) Tablets

Paxil
(paroxetine) Tablets and Oral Suspension

Manufacturer: GlaxoSmithKline

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 6/22/04)

New Warnings, Precautions: Paxil (paroxetine) labeling has been revised to warn healthcare providers of potential safety issues with antidepressants and pediatric patients. The labeling changes describe that 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 changes include a new warning recommending close observation of adult and pediatric patients treated with antidepressant drugs for worsening depression or the emergence of suicidality, particularly at the beginning of treatment or at the time of dose increases or decreases.

Paroxetine is not approved for use in the pediatric population, and clinical trials for paroxetine failed to demonstrate efficacy in pediatric depression.

Reference

Paxil (paroxetine) Tablets and Oral Suspension Labeling

Medscape DrugInfo

Paxil (paroxetine) Tablets and Oral Suspension

Serzone
(nefazodone) Tablets

Manufacturer: Bristol-Myers Squibb

Drug Approval Classification: Original New Drug Application (Approval Date: 06/18/04)

New Warnings, Precautions: Serzone (nefazodone) labeling has been revised to include a warning concerning the emergence of suicidal ideation and/or attempts in patients taking antidepressants. The labeling includes specific attention for practitioners and patients about the need for close observation of patients being treated with antidepressants for clinical worsening of the symptoms of depression, for the emergence of suicidality, and for the emergence of a variety of other symptoms that may represent a worsening of the patient's condition.

The risk of hepatic failure associated with nefazodone has been revised in the product labeling.

Nefazodone is not approved for use in treating any indications in the pediatric population.

Reference

Serzone (nefazodone) Tablets Labeling

Medscape DrugInfo

Serzone (nefazodone) Tablets

Wellbutrin
(bupropion hydrochloride) Extended-Release Tablets

Manufacturer: GlaxoSmithKline

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 6/22/04)

New Warnings, Precautions: Wellbutrin (bupropion) labeling has been revised to warn healthcare providers of potential safety issues with antidepressants and pediatric patients. The labeling changes describe that 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 changes include a new warning recommending close observation of adult and pediatric patients treated with antidepressant drugs for worsening depression or the emergence of suicidality, particularly at the beginning of treatment or at the time of dose increases or decreases.

Bupropion is not approved for use in the pediatric population.

Reference

Wellbutrin (bupropion hydrochloride) Extended-Release Tablets

Medscape DrugInfo

Wellbutrin (bupropion hydrochloride) Extended-Release Tablets

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