Welchol Helps Lower LDL Cholesterol in Pediatric Patients with Hypercholesterolemia

 

October 12, 2009

Daiichi Sankyo Inc. offers Welchol (colesevelam HCl) for children and teens with heterozygous familial hypercholesterolemia (heFH).

The October 2009 FDA clearance allows the drug to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, 10 to 17 years of age, with heFH alone or in combination with a statin after failing an adequate trial of diet therapy. Originally approved in 2000 for LDL-C lowering and in 2008 for A1C reduction in adults, Welchol is approved as an adjunct to diet and exercise to reduce elevated LDL-C in adults with primary hyperlipidemia and improve glycemic control in adults with type 2 diabetes mellitus.

The FDA also approved Welchol (colesevelam HCl) for oral suspension, providing an alternative to the current tablet formulation. Welchol for Oral Suspension is indicated as an adjunct to diet and exercise to improve both glycemic control in adults with type 2 diabetes mellitus, and to reduce elevated LDL cholesterol in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with a hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (a statin). Welchol for Oral Suspension is also indicated for use as an adjunct to diet and exercise for the reduction of elevated LDL-C in boys and post-menarchal girls, 10 to 17 years of age, with heFH alone or in combination with a statin after failing an adequate trial of diet therapy. The recommended dose of Welchol for Oral Suspension is one 3.75 gram packet once daily.

Welchol is contraindicated in individuals with bowel obstruction, those with serum triglyceride concentrations of more than 500 mg/dL, or with a history of hypertriglyceridemia-induced pancreatitis.

For more information: www.Welchol.com

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