Stolen Levemir Insulin Poses Safety Risk
The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.
The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots. The agency is advising patients who use and caregivers who administer Levemir insulin to check the lot numbers on the insulin box or vial. The stolen lot numbers are: XZF0036, XZF0037, and XZF0038. Patients also are advised to carefully inspect their insulin Levemir is a clear and colorless solution. Improper storage of the stolen vials may cause changes in clarity or color.
Patients or caregivers who encounter stolen vials are advised to contact the Novo Nordisk Customer Care Center at 800-727-6500 for further instructions.
Susanne Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN, of S & D Comprehensive Consulting Inc. is a contributor to Gannett Healthcare Group.
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Stimulant Medications Should Not be Discontinued
Based upon review of a recently released study of stimulant medication safety in children, the FDA determined that study findings should not serve as a basis for parents to stop a childs stimulant medication.
The study included 1,128 healthy children who experienced sudden death, of which 12 were taking stimulants. Products involved include: Focalin; Focalin XR (dexmethylphenidate HCl); Dexedrine; Dexedrine Spansules; Dextroamphetamine ER; Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta; Daytrana; Metadate CD; Metadate ER; Methylin; Methylin ER; Ritalin; Ritalin-LA; Ritalin-SR (methylphenidate); Adderall; Adderall XR (mixed salts amphetamine); Cylert (pemoline); and generics.
Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional. Providers should continue to screen children and adolescents for underlying cardiac disease that would make stimulant use contraindicated.