NEW FORMULATION Welchol Oral Suspension for Glycemic Control, Cholesterol

The FDA has approved an oral suspension of colesevelam (Welchol) (alone or with a statin) for patients with difficulty swallowing tablets. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes and to reduce elevated LDL-C levels in adults with primary hyperlipidemia (Fredrickson type IIa). Colesevelam is also used as an adjunct to diet and exercise for reducing elevated LDL-C levels in boys and menarchal girls 10 to 17 years of age and who have heterozygous familial hypercholesteremia after they have tried dietary modifications. The recommended dose is one 3.75-gram packet once daily.

To avoid esophageal distress, patients should not take the suspension in its dry form. The suspension contains 48 mg of phenylalanine per 3.75-gram dose.

Source: Daiichi Sankyo, October 7, 2009