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Label Changes for:

Welchol (colesevelam HCl) Tablets and Oral Suspension

July 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

July 2012 

ADVERSE REACTIONS

DRUG INTERACTIONS

Drugs that do not interact with colesevelam based on in vitro or in vivo testing

  • enalapril
  • atenolol
  • aspirin
  • rosiglitazone
  • sitagliptin
  • phenytoin
  • olmesartan

Drugs with a known interaction with colesevelam: Decrease in exposure of coadministered drug

  • glimepiride

Drugs with a known interaction with colesevelam: Increase in exposure of coadministered drug

  • Metformin ER

Drug(s) with postmarketing reports consistent with potential drug-drug interactions when coadministered with Welchol

  • phenytoin 

 

January 2012

ADVERSE REACTIONS

6.2 Post-Marketing Experience

Gastrointestinal Adverse Reactions

  • ..... dysphagia (tablet and oral suspension formulations).....

 

September 2010

 

DRUG INTERACTION

  • cyclosporine
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