New Warning on Effexor Overdoses
Reported Overdoses Mainly Seen When Taken With Alcohol or Other Drugs
Oct. 25, 2006 -- The antidepressant drug Effexor has new labeling about
reported overdoses, mainly when the drug is taken with alcohol and/or other
The label notes published studies showing that Effexor's risk of fatal
overdoses may be higher than the class of antidepressants known as selective
serotonin reuptake inhibitors (SSRIs). The label also notes that the
fatal-overdose risk is lower than that of older depression drugs
called tricyclic antidepressants.
SSRIs include Prozac, Paxil, Celexa, and Zoloft. Tricyclic antidepressants
include Elavil and Norpramin.
News about the new labeling comes from the FDA and Wyeth, the drug company
that makes Effexor.
Wyeth sent doctors a letter dated Oct. 17 about the label changes. That
letter is posted on the FDA's web site.
The label changes also apply to Effexor's extended-release version, Effexor
Wyeth's letter states that the most commonly reported Effexor overdose
effects include fast heart rate, changes in consciousness (ranging from
sleepiness to coma), seizures, vomiting, and eye
The letter also notes that death, electrocardiogram (EKG) changes, slow
heart rhythms, low blood pressure, vertigo, toxic buildup of
chemicals from dying muscle cells, and liver cell death have also been reported
with Effexor overdoses.
Wyeth's letter doesn't mention how many reports it has gotten of Effexor
overdoses or how many of those overdoses were fatal.
In the letter, Wyeth notes that the studies showing higher risk of fatal
overdoses with Effexor compared with SSRIs (and lower risk compared with
tricyclic antidepressants) don't show whether those patterns were due to
Effexor or to some other factor.
Wyeth's letter also states that "all antidepressants have a potential
risk of fatal outcome in overdoses."
The drug company recommends that doctors prescribe Effexor in "the
smallest quantity of the drug consistent with good patient management, in order
to reduce the risk of overdose."
Wyeth is a WebMD sponsor.