WASHINGTON (CN) – Powder forms of prescription drugs colesevelam hydrochloride and sevelamer carbonate are exempted from child-resistant packaging requirements, according to the Consumer Product Safety Commission.
Colesevelam hydrochloride, marketed as Welchol, is to reduce elevated LDL cholesterol levels and improve glycemic control in adults with type 2 diabetes mellitus. Sevelamer carbonate, marketed as Renvela, is for the control of elevated serum phosphorus in chronic kidney disease patients on dialysis.
The rule exempts these products on the basis that child-resistant packaging is not needed to protect young children from serious injury or illness from powder formulations of these drugs because the products are not acutely toxic, lack adverse human experience associated with acute ingestion, and, in powder form, are not likely to be ingested in large quantities by children under five years of age.
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