Archive for October 26th, 2007

Strattera Side Effects in Adults — FDA NDA

The FDA requires pharma manufacturers to include “New Drug Application” (NDA) data in some of their packaging inserts.  Here is an excerpt of the side effects data for Strattera:

Commonly observed adverse events in acute adult placebo-controlled trials — Commonly
observed adverse events associated with the use of STRATTERA (incidence of 2% or greater) and not observed at an equivalent incidence among placebo-treated patients (STRATTERA incidence greater than placebo) are listed in Table 2. The most commonly observed adverse events in patients treated with STRATTERA (incidence of 5% or greater and at least twice the incidence in placebo patients) were: constipation, dry mouth, nausea, appetite decreased, dizziness, insomnia, decreased libido, ejaculatory problems, impotence, urinary hesitation and/or urinary retention and/or difficulty in micturition, and dysmenorrhea.

Source: Strattera NDA 21-411 (p. 16)  The NDA also includes other conditions that prompted subjects to drop out of the test.