Information on Heparin
Serious injuries and deaths have been associated with the use of heparin, a blood-thinning drug that contained active pharmaceutical ingredient (API) from China. The adverse events have included allergic or hypersensitivity-type reactions, with symptoms such as low blood pressure, angioedema, shortness of breath, nausea, vomiting, diarrhea, and abdominal pain.
In February 2008, Baxter Healthcare Corporation recalled multi-dose and single-dose vials of heparin sodium for injection, as well as HEP-LOCK heparin flush products. After launching a far-ranging investigation, FDA scientists identified a previously unknown contaminant in the heparin. Contaminated heparin has also been found in association with some medical devices, such as certain catheters. Some of these medical devices have been recalled. For additional information about potentially contaminated medical devices and recalls, please refer to the Center for Devices and Radiological Health Questions and Answers. The agency is continuing to aggressively investigate the situation.
Information for Healthcare Providers and Facilities
Information for Manufacturers
Questions and Answers
News and Press Conferences
FDA's Role (3/14/2008)
Information for Healthcare Professionals and Facilities
Public Health Advisories and Updates
Adverse Event Reports
Notices to Manufacturers/Initial Distributors of Medical Devices
** New Information ** (7/7/2008)
The United States Pharmacopeia (USP) has recently published updated compendial test methods for heparin sodium USP to include the two screening tests previously posted on FDA’s website. Effective immediately, in accord with section 501(b) of the FD&C Act, all heparin sodium USP must meet compendial requirements as specified at the following link http://www.usp.org/hottopics/heparin.html.
All other measures used to prevent contaminated heparin products from entering the US should remain in place, and we request that all heparin suppliers and manufacturers continue reporting results to FDA as outlined in the section "Heparin Test Results" until further notice.
Heparin Test Results
To ensure the safety of heparin products in the United States market, the FDA has asked companies that manufacture heparin-containing products to test the heparin active pharmaceutical ingredient (API) used in those products using capillary electrophoresis (CE) and the updated proton nuclear magnetic resonance (H-NMR) methods provided in the “Screening Methods” section of this website. As part of FDA’s ongoing investigation, the FDA has updated the information it is requesting from manufacturers to allow a better understanding of the complex global heparin supply chain and to ensure the safety of heparin containing products for use in the United States.
In order to promote consistency in the information reporting and gain the most benefit from these reporting activities, the FDA is requesting monthly updates from manufacturers on all heparin API testing using the template provided below. However, FDA should be notified of any positive results within 3 days of the test being conducted. In addition, FDA requests that manufacturers submit the associated NMR spectra and CE electropherograms that support the testing results to the address below.
Please send all test results to the U.S. FDA at: email@example.com using the following template (in Microsoft Excel format).
Heparin Analytical Result Reporting Sheet.xls
FDA has provided the following sample spreadsheet in order to illustrate proper use of the spreadsheet.
SAMPLE Heparin Analytical Result Reporting Spreadsheet.xls
Countries with Contaminated Heparin API (4/21/2008)
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Date created: February 11, 2008, updated July 7, 2008