Effexor (venlafaxine
HCl) overdosage may be associated with an increased risk of fatal outcome
FDA
approves quetiapine for treatment of bipolar depression
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Source:
Food
and Drug Administration (FDA)
Wyeth and FDA notified healthcare professionals of revisions to the
OVERDOSAGE/Human Experience section of the prescribing information for Effexor (venlafaxine
HCl), indicated for treatment of major depressive disorder. In postmarketing
experience, there have been reports of overdose with venlafaxine, occurring
predominantly in combination with alcohol and/or other drugs.
Published
retrospective studies report that venlafaxine overdosage may be associated with
an increased risk of fatal outcome compared to that observed with SSRI
antidepressant products, but lower than that for tricyclic antidepressants. Healthcare professionals are advised to prescribe Effexor and Effexor XR in the
smallest quantity of capsules consistent with good patient management to reduce
the risk of overdose.
Read the complete MedWatch 2006 Safety summary, including links to the Dear
Healthcare Professional letter and revised label, at:
Link:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Effexor
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Source:
European CHMP (Committee for Medicinal Products for Human Use)The European CHMP has recommended the addition of new contraindications to duloxetine containing products (Yentreve® and Cymbalta®) to state that treatment
should not be initiated in patients with uncontrolled hypertension that could expose them to a potential risk of a hypertensive crisis. For Yentreve, the committee also recommended that it should not be used in patients with severe renal impairment; this contraindication is already included in the product information for Cymbalta.
Link:
http://www.emea.eu.int/pdfs/human/press/pr/42102706en.pdf
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Editor:
Luis I. Mariani
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