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New Data Demonstrated Efficacy and Safety of Initial Combination Therapy with Welchol(R) (colesevelam HCl) and Metformin in Drug-Naive Adult Type 2 Diabetes Patients
Date:6/26/2010

3.2% vs 3.1%), and myalgia (2.1% vs 0.4%)
  • Adult patients with Type 2 Diabetes were: constipation (8.7% vs 2.0%), nasopharyngitis (4.1% vs 3.6%), dyspepsia (3.9% vs 1.4%), hypoglycemia (3.0% vs 2.3%), nausea (3.0% vs 1.4%), and hypertension (2.8% vs 1.6%)

  • Post-marketing experience: Due to the voluntary nature of these reports it is not possible to reliably estimate frequency or establish a causal relationship:

    • Increased seizure activity or decreased phenytoin levels have been reported in patients receiving phenytoin concomitantly with Welchol
    • Reduced International Normalized Ratio (INR) has been reported in patients receiving warfarin concomitantly with Welchol
    • Elevated thyroid-stimulating hormone (TSH) has been reported in patients receiving thyroid hormone replacement therapy

    Pregnancy

    Welchol is Pregnancy Category B.

    Please visit http://www.welchol.com/pdf/Welchol_PI.pdf for full Prescribing Information on Welchol.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    For more information on Welchol, call 877-4-DSPROD (877-437-7763), or go to the Welchol web site at

    SOURCE Daiichi Sankyo
    Copyright©2010 PR Newswire.
    All rights reserved

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