Voluntary batch recall medicinal specialty LESCOL used in diet therapy
Voluntary recall lot specialty drug “LESCOL” used in diet therapy
The Novartis Company by its own note dated August 30, 2016, informed that it intends to proceed, as a precautionary measure, with the voluntary recall of the packages in the distribution channel belonging to the lot B2014 expired. 9/2017 of the medicinal specialty LESCOL*28CPS 20MG – AIC 029163019.This initiative is due to the finding of out-of-specification results of some of the degradation products at 18 months.
The Novartis Company further specifies that what was found is not such as to result in a potential change in the risk-benefit ratio of the drug or to result in any risks to patients that could take the form of a safety issue. LESCOL is used to treat, in addition to diet, primary hypercholesterolemia or mixed-type dyslipidemia in adults when the response to diet and other nonpharmacological treatments (such as. Exercise, weight reduction) is not adequate.
The active ingredient of this drug is Fluvastatin, which is a chemically synthesized complete hypolipidemic compound belonging to the statin family that is used in combination with diet, physical activity and weight loss research to reduce hypercholesterolemia, treat associated conditions and prevent cardiovascular disease. The drug is basically a racemate of two erythro-enantiomers, the’eutomer of which is responsible for the pharmacological activity. In Italy the drug is sold by the pharmaceutical company Novartis under the trade name Lescol.
Following patent expiration, it is also being marketed by several other pharmaceutical companies as a generic drug. Any stocks of the batch involved, points out Giovanni D’Agata, president of the “Sportello dei Diritti” should no longer be dispensed and should be returned, with the first useful tranche, to Assinde, which will recognize the reimbursement.