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Wyeth reports off-label use of venlafaxine associated with pediatric risks

October 1, 2003

Article

A recent "Dear Healthcare Professional" letter issued by Wyeth outlines the potential risks associated with the company's antidepressant venlafaxine (Effexor and Effexor XR) when the drug is administered in the pediatric population. The letter, dated August 22, 2003, cites data from clinical studies in pediatric patients (aged 617 y) and details changes that have been made to the labeling for venlafaxine. Venlafaxine has been prescribed off-label in the pediatric population despite never being approved by FDA for use in children or adolescents.

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If approved, Linzess would be the first prescription therapy for functional constipation in children and adolescents 6 to 17 years of age.

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Eylea is being reviewed as a treatment for retinopathy in premature infants.

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