KEPADA DOKTOR DAN PENGAMAL PERUBATAN MODEN ATAU MEREKA YANG SELALU BERJUMPA DOKTOR (SILA BACA)

SILA PASTIKAN BOTOL LABEL UBAT ANDA TIDAK MENGANDUNGI BAHAN INI

Apa itu heparin?? (WHAT IS HAPARIN)

Drug Information Heparin Update

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

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.

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