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U.S. Department of Health and Human Services

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Heparin Sodium Injection (Feb 2008)

Audience: Surgeons, dialysis center staff, hospital risk managers, and other healthcare professionals

[UPDATE 05/15/2008] Atrium Medical Corporation announced that it is initiating a voluntary and precautionary recall of selected lots of Hydraglide Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS).

[UPDATE 05/15/2008] Medtronic Inc., initiated a voluntary recall of selected products featuring the Carmeda BioActive surface. The recalled products are used during cardiopulmonary bypass heart surgeries. Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). It is unclear if exposure to Carmeda-coated medical devices, made with small amount of heparin, could cause adverse events similar to those observed with injectable heparin formulations. Patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time.

Medtronic is also advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. The amount of heparin on the product is significantly lower than that contained on the Carmeda product. Based on current data, the benefit of using the affected products outweighs any potential risk to patients. The maximum possible patient exposure to heparin from Trillium is extremely low; therefore, customers can continue to use the affected Trillium products until a replacement is available.

[UPDATE 05/09/2008] FDA requested that health professionals and facilities review and examine all drug/device storage areas, including emergency kits, dialysis units and automated drug storage cabinets to ensure that all recalled heparin products have been removed and are no longer available for patient use. In addition, FDA informed health professionals about other types of medical devices that contain, or are coated with, heparin.

[UPDATE 04/29/2008] Update to healthcare facilities and healthcare professionals about Heparin and Heparin-containing medical products.

[UPDATE 02/28/2008] Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions.

[Posted 02/11/2008] FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.

[May 12, 2008 - Press Release - Atrium]
[May 07, 2008 - Press Release - Medtronic]
[April 25, 2008 - Information on Heparin Sodium Injection - FDA/CDER]
[April 25, 2008 - Update to Healthcare Facilities and Healthcare Professionals - FDA/CDRH]
[March 07, 2008 - Updated Questions and Answers - FDA]
[February 28, 2008 - Public Health Update - FDA]
[February 28, 2008 - Press Release - Baxter]
[February 11, 2008 - Public Health Advisory - FDA] UPDATED 02/28/2008
[February 11, 2008 - Questions and Answers - FDA]
[February 11, 2008 - News Release - FDA]

Previous MedWatch alert:

[January 18, 2008]