1 / 14

Serious adverse events following falsely high glucose measurements resulting from administration of an IGIV product cont

Serious adverse events following falsely high glucose measurements resulting from administration of an IGIV product containing maltose. L. Ross Pierce, M.D. Medical Officer, Clinical Review Branch, Div. of Hematology, FDA.

roz
Download Presentation

Serious adverse events following falsely high glucose measurements resulting from administration of an IGIV product cont

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Serious adverse events following falsely high glucose measurements resulting from administration of an IGIV product containing maltose L. Ross Pierce, M.D. Medical Officer, Clinical Review Branch, Div. of Hematology, FDA

  2. Popularity and Pitfalls of Glucose Meter Testing – Adverse Drug/Device Interaction • Point-of-care capillary blood glucose meters widely used in hospitals/clinics and at home. • Test strips using Glucose Dehydrogenase Pyrrolo-Quinoline Quinone (GDH-PQQ) not specific for glucose – only some bear PRECAUTION in PI. • Non-specific glucose test methods still inappropriately used in patients who are receiving parenteral maltose-containing products (some IGIVs)

  3. Two Different Glucose Dehydrogenase Enzymes • GDH-PQQ does not contain NAD • Uses EITHER glucose or maltose as substrates • Used in many test strip systems. • NAD-dependent Glucose Dehydrogenase • Uses glucose but NOT maltose as substrate • Used in > 1 glucose meter test strip system.

  4. BIOCHEMICAL, CHEMICAL, & ELECTROCHEMICAL REACTIONSTHAT OCCUR DURING GDH-PQQ ASSAYS

  5. BIOCHEMICAL, CHEMICAL, & ELECTROCHEMICAL OR COLORIMETRIC REACTIONSTHAT OCCUR DURING GDH-PQQ ASSAYS

  6. Relevant Redox Forms of PQQ

  7. Enzyme Specificity (Maltose Interference)

  8. Maltose Interference GDH-PQQ NAD-independent Point of Care Glucose Meters (Electrode) Point of Care Colorimetric systems (e.g.,”glucose-dye-oxidoreductase”) No PaO2 effect No Maltose Interference NAD-dependent GDH (no PaO2 effect) Hexokinase (low PaO2 interferes) Glucose Oxidase (low PaO2 & mannitol > 5 mg/mL interfere) Parenteral Maltose Causes False Hyperglycemia Results with which Test Systems?

  9. Which IgG products contain maltose? • Octagam 5% (Octapharma) • Gamimune N 5% (Bayer/Talecris) • WinRho SDF Liquid (Cangene) • No interference expected at labeled doses • Vaccinia Immune Globulin (Cangene) • Only available through CDC • Interference expected at labeled doses

  10. What recent actions has CBER taken in response to these adverse events? • Formed CBER/CDRH working group • Strengthen Labeling of maltose-containing IGIVs • Asked sponsors to issue IMPORTANT DRUG WARNING letters to physicians, customers, and hospitals. • Coordination with CDRH and CDER on Health Alerts for FDA websites and MEDWATCH Listservs. • Drafting an article to be submitted widely-circulated medical journal(s).

  11. Work with Sponsors • Revise package inserts Re: potential for falsely elevated blood glucose results: • add a WARNING • strengthen PRECAUTIONS

  12. New Class Labeling for Maltose-Containing IGIVs • Labeling will indicate: • Some types of blood glucose testing systems (e.g. GDH-PQQ or “glucose-dye-oxidoreductase” methods) falsely interpret maltose as glucose. • This has resulted in inappropriate administration of insulin, resulting in life-threatening hypoglycemia.

  13. Class Labeling for Maltose-Containing IGIVs (cont.) • When administering maltose-containing IGIVs, use a glucose-specific method for measuring glucose. • Carefully review the product information of the glucose testing system, including that of the test strips, to determine if the system is appropriate for use in patients receiving maltose-containing parenteral products. Contact the manufacturer of the test system if there is any uncertainty.

  14. References (partial list): • Medical Device Alert. Medicines and Healthcare Products Regulatory Agency. April 16, 2003. • Kannan S et al. Intragam can interfere with blood glucose monitoring. MJA 2004;180:251-252 • ISMP Medication Safety Alert! Sept 8 & 22, 2005. • WWW.Octapharma.com/USA

More Related