        | ||||
    Medication Adverse Event Update May 9, 2008
A summary of the recent FDA Public Health Advisories and recalls on heparin: February 11, 2008 - Reports of serious adverse events including allergic or hypersensitivity reactions associate with Baxter’s multi-dose heparin flush vials. February 28, 2008 - Baxter voluntarily recalled all of their multi- and single-dose heparin injection and lock flush solutions due to reports of adverse events, the underlying cause for the events are unknown at this time. March 7, 2008 - FDA scientists have identified a previously unknown contaminant in the heparin. The agency does not have proof that this contaminant is causing the adverse events. There is an association, but not a direct causal link at this time. March 21, 2008 - B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant. [ Press Release - B. Braun Medical] April 2, 2008 - Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. See the manufacturer's press release for the list of specific lots of the product affected by the recall. [ Press Release - Covidien] April 25, 2008 - FDA scientists have identified a contaminant in the heparin – an oversulfated chondroitin sulfate. The contaminant mimics heparin activity so closely that it was not recognized by routine testing. FDA now has in vitro and animal data demonstrating a solid mechanistic link between the oversulfated chondroitin sulfate and the adverse events observed after bolus dosing. 05/09/08
The following email was sent by the FDA on May 9, 2008: “Please help FDA spread the word about recalls of injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS). Affected heparin products have been found in medical care facilities in one state since the recall announcement. Although product recall instructions were widely distributed, they may not have been fully acted upon at all sites where heparin is used. There have been many reports of deaths associated with allergic or hypotensive symptoms after heparin administration. Please see FDA link at http://www.fda.gov/cder/drug/infopage/heparin/adverse_events.htm . We ask that health professionals and facilities please review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all of the recalled heparin products have been removed and are no longer available for patient use. In addition, FDA would like to inform health professionals about other types of medical devices that contain, or are coated with, heparin. To read this update, and to learn how to report these problems to FDA, please go to: http://www.fda.gov/cdrh/safety/heparin-healthcare-update.html . Please report to FDA adverse reactions associated with these devices, as well as any reactions associated with heparin or heparin flush solutions.”
Analysis from RxAmerica’s Clinical Services:
|
||||
     |
