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Welchol
Generic Name: Colesevelam Hydrochloride
Drug Category: Bile Acid Sequestrant
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 10 years old for a maximum duration of 50 weeks.
| Approved Uses |
|
Indicated as an adjunct to diet and exercise for: Primary Hyperlipidemia: • To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. • To reduce LDL-C levels in boys and postmenarchal girls,10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification. Type 2 Diabetes Mellitus: • To improve glycemic control in adults with type 2 diabetes mellitus. WELCHOL should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. The effect of WELCHOL on cardiovascular morbidity and mortality has not been determined. WELCHOL has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor. WELCHOL has not been studied in pediatric patients with type 2 diabetes. WELCHOL has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. WELCHOL has not been studied in children younger than 10 years of age or in premenarchal girls. WELCHOL is contraindicated in patients with:
Obtain lipid parameters, including triglyceride (TG) levels, before starting WELCHOL. WELCHOL may decrease the absorption of fat-soluble vitamins A, D, E, and K. Patients with a susceptibility to deficiencies of vitamin K (e.g., patients on warfarin, patients with malabsorption syndromes) or other fat-soluble vitamins may be at increased risk when taking WELCHOL. Patients on oral vitamin supplementation should take their vitamins at least 4 hours prior to WELCHOL. WELCHOL, like other bile acid sequestrants, can increase serum TG concentrations. Hypertriglyceridemia can cause acute pancreatitis. Postmarketing cases of bowel obstruction have occurred with WELCHOL. Because of its constipating effects, WELCHOL is not recommended in patients with gastroparesis, other gastrointestinal motility disorders, and in those who have had major gastrointestinal tract surgery and who may be at risk for bowel obstruction. Phenylalanine can be harmful to patients with PKU. WELCHOL for oral suspension contains phenylalanine, a component of aspartame. Drugs with a known interaction with colesevelam (e.g., cyclosporine, glimepiride, glipizide, glyburide, levothyroxine, olmesartan medoxomil, oral contraceptives) should be administered at least 4 hours prior to WELCHOL. There is a decrease in exposure of these drugs when used with colesevelam. Concomitant use of WELCHOL and warfarin has been associated with reduced INR. Increase in metformin extended release when co-administered with WELCHOL. There have been post-marketing reports of increased seizure activity or decreased phenytoin levels in patients receiving phenytoin. There have been post-marketing reports of elevated thyroid-stimulating hormone (TSH) in patients receiving thyroid hormone replacement therapy. Olmesartan medoxomil is decreased when co-administered with WELCHOL. Decrease in sulfonylureas (e.g., glimepiride, glipizide, and glyburide) when co-administered with WELCHOL. Use of WELCHOL may reduce the efficacy of oral contraceptives. Advise patients to take oral WELCHOL may decrease the absorption of fat-soluble vitamins A, D, E, and K. The effect of colesevelam on the absorption of fat-soluble vitamins has not been studied in pregnant women. WELCHOL is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Limited available data on the use of WELCHOL are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. WELCHOL is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to WELCHOL. |
| Off-label Uses |
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• Irritable bowel syndrome with diarrhea. GoToSource • Use in patients under the age of 10. GoToSource • Type 1 diabetes or diabetic ketoacidosis. GoToSource • Pruritus in cholestasis. GoToSource • Crohn’s disease. GoToSource • Bile acid malabsorption. GoToSource |
| Adverse Events |
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Constipation. GoToSource Dyspepsia (indigestion). GoToSource Diverticulitis and hypoglycemia (low blood sugar). GoToSource Upper respiratory tract infection, increased serum triglyceride levels and increased risk of pancreatitis. GoToSource Urinary tract infections. GoToSource Decreased absorption of vitamins A, D, E, K. GoToSource Myalgia (muscle pain). GoToSource Increased AP, AST, and ALT levels (indication of liver injury). GoToSource |
| Litigation |
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No major injury lawsuits reported. |
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