Effexor (venlafaxine HCl) overdosage may be associated with an increased risk of fatal outcome

FDA approves quetiapine for treatment of bipolar depression

European CHMP recommends adding new contraindications to duloxetine containing products (Yentreve and Cymbalta)

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Effexor (venlafaxine HCl) overdosage may be associated with an increased risk of fatal outcome

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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FDA approves quetiapine for treatment of bipolar depression

Source:
Food and Drug Administration (FDA)

The USA Food and Drug Administration (FDA) has approved quetiapine (Seroquel) for the treatment of bipolar depression.
The drug is already licensed in the UK and USA for the treatment of acute manic episodes associated with bipolar disorder.


Link:
http://www.fda.gov/medwatch/SAFETY/2004/Seroquel-lbl.pdf 

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European CHMP recommends adding new contraindications to duloxetine containing products (Yentreve and Cymbalta)

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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Boletín de Actualización en Neuropsicofarmacología (BAN)
Editor: Luis I. Mariani
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Número de Suscriptos:
964 

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