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U.S. Department of Health and Human Services

Safety

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Welchol (colesevelam) Tablets and Oral Suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Phenylketonurics
  • Welchol for Oral Suspension contains 13.5 mg phenylalanine per 1.875 gram packet and 27 mg phenylalanine per 3.75 gram packet
 

ADVERSE REACTIONS

Clinical Studies Experience
Type 2 Diabetes Mellitus:
  • The safety of WELCHOL in patients with type 2 diabetes mellitus was evaluated in 4 add-on combination and 1 monotherapy double-blind, 12-26 week, placebo-controlled clinical trials. The add-on combination trials involved 1128 patients (566 patients on Welchol; 562 patients on placebo) with inadequate glycemic control on metformin, sulfonylurea, or insulin when these agents were used alone or in combination with other anti-diabetic agents. Upon completion of the add-on combination trials...
  • In the monotherapy diabetes trial, a total of 4.6% of Welchol-treated patients and 4.7% of placebo-treated patients were discontinued from the trial due to adverse reactions.
  • Hypertriglyceridemia
  • In the monotherapy diabetes trial, the distribution of baseline fasting serum TG levels was similar to that from the add-on combination trials. The median baseline fasting TG for the monotherapy study population was 167 mg/dL; the median post- treatment fasting TG concentration was 182mg/dL in the Welchol group and 173mg/dL in the placebo group. Welchol treatment resulted in a median placebo-corrected increase in serum TG of 9.7% (p=0.03).
 

USE IN SPECIFIC POPULATIONS

Geriatric Use
  • Type 2 Diabetes Mellitus
  • Of the 357 patients enrolled in the monotherapy diabetes trial, 28 (8%; 11 Welchol and 17 placebo) were ≥65 years old, too few to determine whether they respond differently from younger patients. 
Renal Impairment
  • Of the 357 patients enrolled in the monotherapy diabetes trial, only 3 patients had CrCl <50 mL/min.