News | June 30, 2008

FDA Gives Update on Contaminated Heparin

July 1, 2008 - The FDA is asking healthcare professionals and facilities check all drug and device storage areas, including emergency kits, crash carts and automated drug storage cabinets to make sure all recalled heparin products have been removed and are no longer available for use.

"The investigation of contaminated heparin is still underway. Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events.

Heparin is an anticoagulant commonly used subcutaneously and intravenously in patients undergoing kidney dialysis, certain types of cardiac surgery and other procedures. It is also used in lock flush solutions to maintain the patency of IV catheters, and as a coating or ingredient in certain medical devices and diagnostic products."

Towards the end of 2007, FDA started receiving an increasing number of reports of adverse events associated with injectable heparin products, especially when the heparin was administered as a bolus dose. Many of these events were consistent with either an anaphylactic-type reaction or acute hypotension. A small number of similar events have also been reported for heparin flush solutions.

FDA has identified a contaminant in the heparin, an oversulfated chondroitin sulfate, that may have led to the adverse events. "This contaminant mimics heparin activity so closely that routine testing did not uncover it. Special test methods are needed to detect this contaminant, and the major U.S. heparin manufacturers and suppliers have agreed to perform these tests to screen all heparin active ingredient they receive." The FDA has also asked medical device companies to identify any product they market that contains heparin or uses heparin in processing. A number of companies have recalled heparin or products containing heparin. They did this based either on reports of adverse events or as a precaution after the special testing revealed that the company had been supplied with contaminated lots of heparin. "¨"¨

FDA is asking healthcare professionals and facilities to report adverse reactions associated with any drug or device that contains heparin. FDA said it is continuing to actively monitor this situation and it is essential 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. The FDA also recommends paying close attention to recalls of heparin or heparin-containing products, including those by Baxter Healthcare, American Health Packaging, B. Braun, Covidien, Medtronic and Atrium Medical.

For more information: www.fda.gov/cder/drug/infopage/heparin/default.htm#healthcare

Related Content

Coronary CT angiography images of a coronary artery depicting the perivascular fat attenuation index (FAI) before and after biologic therapy at one-year follow-up. Patients had excellent response to biologic therapy, showing clear reductions in the inflammation in plaques that cause heart attacks and stokes. Image from the Oxford Academic Cardiovascular CT Core Lab and Lab of Inflammation and Cardiometabolic Diseases at NHLBI.

Coronary CT angiography images of a coronary artery depicting the perivascular fat attenuation index (FAI) before and after psoriasis biologic drug therapy at one-year follow-up. Patients had excellent response to biologic therapy, showing clear reductions in the inflammation in plaques that cause heart attacks and stokes. Image from the Oxford Academic Cardiovascular CT Core Lab and Lab of Inflammation and Cardiometabolic Diseases at NHLBI.

 

Feature | Pharmaceuticals | July 31, 2019
July 31, 2019 — Researchers found anti-inflammatory drug therapies used to treat moderate to severe psoriasis can sig
Quantum Genomics Enrolls First Patient in QUORUM Phase IIb Study of Firibastat
News | Pharmaceuticals | June 14, 2019
Quantum Genomics announced the enrollment of the first patient in its QUORUM Phase IIb study of its lead clinical...
FDA Grants Priority Review for Vascepa sNDA
News | Pharmaceuticals | May 29, 2019
Amarin Corp. plc announced that its supplemental new drug application (sNDA) for Vascepa (icosapent ethyl) capsules has...
Vascepa Markedly Reduces First, Repeat and Total Cardiovascular Events
News | Pharmaceuticals | March 29, 2019
Taking a high dose of icosapent ethyl significantly reduces the occurrence of first, subsequent and total ischemic...
Bempedoic Acid Combination Tablet Significantly Lowers LDL-Cholesterol

Image courtesy of Esperion

News | Pharmaceuticals | March 25, 2019
Phase 3 results from Study 2, also known as CLEAR WISDOM, of bempedoic acid were recently presented at the American...
Aurobindo Pharma Adds to Nationwide Valsartan Blood Pressure Medication Recall
News | Pharmaceuticals | January 10, 2019
January 10, 2019 — Aurobindo Pharma USA Inc.
Mylan Expands Nationwide Recall of Valsartan Blood Pressure Medication
News | Pharmaceuticals | December 11, 2018
December 11, 2018 — Mylan Pharmaceuticals is expanding its consumer-level voluntary nationwide recall to include all
Farxiga Reduces Heart Failure Hospitalization, Cardiovascular Death for Type 2 Diabetes
News | Pharmaceuticals | November 15, 2018
AstraZeneca announced positive full results from the DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for...
Vascepa and Statins Significantly Reduce Cardiovascular Events in the REDUCE-IT trial. #AHA #AHA18 #AHA2018
News | Pharmaceuticals | November 13, 2018
A study in the current edition of the New England Journal of Medicine shows that a particular treatment significantly...
Overlay Init