Effexor labelling updated to reflect overdose warnings
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Effexor labelling updated to reflect overdose warnings The prescribing information for Effexor XR [venlafaxine] extended-release capsules and Effexor [venlafaxine] tablets has been updated to highlight information regarding venlafaxine overdose, according to a ‘Dear Health Care Provider’ letter issued by Wyeth, which was posted on the US FDA website. The Overdosage/Human Experience section has been updated to highlight the following: • Venlafaxine overdose has occurred mostly in combination with other drugs and/or alcohol, in the postmarketing experience. The most commonly reported events in overdose include changes in consciousness, seizures, mydriasis, tachycardia and vomiting. • Published retrospective studies suggest that venlafaxine overdose may be associated with an increased risk of fatal outcomes compared with that observed with SSRI antidepressants, but lower than that observed with tricyclic antidepressants. • Epidemiological research has indicated that venlafaxine recipients have a greater pre-existing burden of risk factors for suicide versus recipients of SSRIs; it is unclear to what extent the increased risk of fatal outcomes can be attributed to venlafaxine’s toxicity in overdoses as opposed to the characteristics of venlafaxine recipients. • To reduce the risk of overdose, Effexor and Effexor XR should be prescribed in the smallest quantity of capsules in line with good patient management. Wyeth. Prescribing Information regarding Effexor XR (Rm) (venlafaxine HCl) Extended-Release Capsules and Effexor (Rm) (venlafaxine HCl) Tablets. Company Communication : [3 pages], 17 Oct 2006. Available from: URL: http:// 801013732 www.fda.gov
0114-9954/10/1126-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 4 Nov 2006 No. 1126
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