Pharmacy Services
Antidepressant Labeling Changes
July 6, 2004
The product labeling has changed for several antidepressants to include new warnings about adverse events. The labeling for paroxetine (Paxil), bupropion (Wellbutrin, Zyban), venlafaxine (Effexor), and nefazodone (Serzone) now include a warning about the potential for suicidal ideation in patients with depression.
Product labeling for Effexor also includes a warning about prolonged hospitalization of neonates exposed to SNRIs (serotonin and norepinephrine reuptake inhibitors) or SSRIs (selective serotonin reuptake inhibitors). Product labeling for Serzone also includes a new warning about hepatic failure and cautions physicians to consider the risk-benefit for the patient. Name brand Serzone has been discontinued by Bristol-Myers Squibb although generic nefazodone products remain available.
Further information concerning these product labeling changes can be found at the FDA MedWatch web site at the following links:
- Paroxetine (Paxil) labeling changes:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm155485.htm - Venlafaxine (Effexor) labeling changes:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm154975.htm - Bupropion (Wellbutrin) labeling changes:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm155510.htm - Nefazodone (Serzone) labeling changes:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm155496.htm
Updated
July 6, 2004; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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