icnmgrjill
07-11-2008, 01:07 PM
From our past newsletters, you know that we’ve been tracking the heparin recall and its impact on the IC community. Heparin is commonly used in many bladder instillations, including the popular rescue instillations which have become a first line therapy for IC patients in clinics around the world.
Late last year, the FDA began receiving hundreds of reports of severe allergic reactions and/or fatalities of patients who were given heparin. The reactions were tracked to a contaminant that, they believe, was deliberately added to the product at a manufacturing plant in China. This led to a series of recalls of heparin solutions both in the USA and abroad.
Late this Spring, the recall took an unexpected turn when the FDA began receiving reports of severe reactions from patients who were exposed to medical devices (i.e. various catheters, heart stents, grafts, etc.) that had been manufactured with heparin. A wide variety of medical devices were recalled and some companies issued precautionary recalls after they determined that they may have used the contaminated heparin in the manufacturing of these devices.
The FDA is continuing their investigation. They are asking healthcare professionals and facilities to take the following steps:
• Report adverse reactions associated with any drug or device that contains heparin. FDA is continuing to actively monitor this situation and it is essential that new events are reported as soon as possible. FDA is focusing on events involving injectable heparin, heparin lock flush solutions or medical devices that contain heparin. That could include certain blood collection tubes, intravascular catheters, vascular stents and grafts, and other devices used during cardiac procedures, such as oxygenators, pumps, filters and blood reservoirs.
• Pay attention to recalls of heparin or heparin-containing products, including those by Baxter Healthcare, American Health Packaging, B. Braun, Covidien, Medtronic and Atrium Medical.
• Check all drug and device storage areas, including emergency kits, crash carts, dialysis units and automated drug storage cabinets, to make sure that all recalled heparin products have been removed and are no longer available for use.
The latter is particularly important for IC patients who may have heparin stockpiled for home instillation use. If you do have any stockpiled heparin, please ask your physician and/or pharmacist to verify that it was produced AFTER the recall. Apparently, the contaminant was introduced in the Fall of 2007.
Additional Information:
FDA. Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products.
http://www.fda.gov/cder/drug/infopage/heparin/default.htm#healthcare
FDA. Information on Heparin Sodium Injection. April 25, 2008.
http://www.fda.gov/cder/drug/infopage/heparin/default.htm
FDA MedWatch Safety Alert. Heparin Sodium Injection. May 15, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2
Late last year, the FDA began receiving hundreds of reports of severe allergic reactions and/or fatalities of patients who were given heparin. The reactions were tracked to a contaminant that, they believe, was deliberately added to the product at a manufacturing plant in China. This led to a series of recalls of heparin solutions both in the USA and abroad.
Late this Spring, the recall took an unexpected turn when the FDA began receiving reports of severe reactions from patients who were exposed to medical devices (i.e. various catheters, heart stents, grafts, etc.) that had been manufactured with heparin. A wide variety of medical devices were recalled and some companies issued precautionary recalls after they determined that they may have used the contaminated heparin in the manufacturing of these devices.
The FDA is continuing their investigation. They are asking healthcare professionals and facilities to take the following steps:
• Report adverse reactions associated with any drug or device that contains heparin. FDA is continuing to actively monitor this situation and it is essential that new events are reported as soon as possible. FDA is focusing on events involving injectable heparin, heparin lock flush solutions or medical devices that contain heparin. That could include certain blood collection tubes, intravascular catheters, vascular stents and grafts, and other devices used during cardiac procedures, such as oxygenators, pumps, filters and blood reservoirs.
• Pay attention to recalls of heparin or heparin-containing products, including those by Baxter Healthcare, American Health Packaging, B. Braun, Covidien, Medtronic and Atrium Medical.
• Check all drug and device storage areas, including emergency kits, crash carts, dialysis units and automated drug storage cabinets, to make sure that all recalled heparin products have been removed and are no longer available for use.
The latter is particularly important for IC patients who may have heparin stockpiled for home instillation use. If you do have any stockpiled heparin, please ask your physician and/or pharmacist to verify that it was produced AFTER the recall. Apparently, the contaminant was introduced in the Fall of 2007.
Additional Information:
FDA. Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products.
http://www.fda.gov/cder/drug/infopage/heparin/default.htm#healthcare
FDA. Information on Heparin Sodium Injection. April 25, 2008.
http://www.fda.gov/cder/drug/infopage/heparin/default.htm
FDA MedWatch Safety Alert. Heparin Sodium Injection. May 15, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2