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U.S. Department of Health and Human Services

Safety

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WelChol (colesevelam hydrochloride) Tablets


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

  • General
  • Serum Triglycerides (TG)
  • Drug Interactions

ADVERSE REACTIONS

  • Clinical Studies Experience
  • Type 2 Diabetes Mellitus
  • Table 2
  • Hypertriglyceridemia
  • Cardiovascular Adverse Events
  • Hypoglycemia

USE IN SPECIFIC POPULATIONS

  • Geriatric Use
    • Type 2 Diabetes Mellitus
  • Renal Impairment
    • Type 2 Diabetes Mellitus

PATIENT COUNSELING INFORMATION

  • Type 2 Diabetes Mellitus
    • General
    • Hypertriglyceridemia and Cardiovascular Disease

CONTRAINDICATIONS

WelChol is contraindicated in patients with:
• A history of bowel obstruction
• Serum TG concentrations >500 mg/dL
• A history of hypertriglyceridemia-induced pancreatitis

WARNINGS AND PRECAUTIONS

See highlighted text for labeling revisions.
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