10/30/2006

The FDA and Wyeth issued an alert and updated the venlafaxine prescribing information to reflect an increased risk of overdose when venlafaxine is combined with alcohol or other medications. Postmarketing surveillance revealed the following signs and symptoms with overdose: tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, seizures, vomiting, ECG changes, ventricular tachycardia, bradycardia, hypotension, rhabdomyolysis, vertigo, liver necrosis, serotonin syndrome and death. Fatal outcomes with venlafaxine may be higher than those observed with SSRI antidepressants, but are lower than tricyclic antidepressants. Clinicians are encouraged to prescribe venlafaxine in small quantities in order to reduce the risk of overdose.

• FDA MedWatch Alert:
  http://www.fda.gov/medwatch/safety/2006/safety06.htm#Effexor
   
• Wyeth Letter to Health Care Providers:
  http://www.fda.gov/medwatch/safety/2006/effexor_DHCPletter.pdf
   
• Revised Prescribing Information – Effexor®:
  http://www.fda.gov/medwatch/safety/2006/effexor_PI.pdf
   
• Revised Prescribing Information – Effexor XR®:
  http://www.fda.gov/medwatch/safety/2006/effexor_xr_PI.pdf