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Information on Heparin

 

Change in Heparin USP Monograph 

The U.S. Food and Drug Administration (FDA) is alerting healthcare providers of a change to the United States Pharmacopeia (USP) monograph for heparin, effective October 1, 2009. 

2008 Heparin Contamination

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.

General Information

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


 Recalls


 Adverse Event Reports


 Notices to Manufacturers/Initial Distributors of Medical Devices


 Screening Methods

** 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: USP Heparin Information.

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 safety of heparin products in the United States, FDA asked manufacturers of heparin-containing products to test the heparin active pharmaceutical ingredient (API) used in these products with the two screening methods posted to FDA's website, capillary electrophoresis (CE) and proton nuclear magnetic resonance (H-NMR).  FDA wants to extend its appreciation to all companies who expeditiously adopted these methods and provided monthly updates.  These methods have been included in the United States Pharmacopeia monograph since June 2008, and are to be used for all products intended for the U.S. market.  Adherence to an appropriate testing regimen will be monitored by our inspection program and enforced by FDA. 

Beginning with the month of March 2009, monthly updates on heparin test results are no longer required.  However, please continue to notify FDA of any positive results within 3 days of the testing.  Provide your positive results, with the associated H-NMR spectra and CE electropherograms to support the test results, using the below template via email to cderrecalls@cder.fda.gov


 Inspectional Observations


 Warning Letters

 

 

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