FaultyDrugs.com » Heparin

Screening Methods For Heparin Manufacturers

Admin — Sun, 27 Jul 2008 08:29:56 +0000

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 dates 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: cderrecalls@cder.fda.gov

Voluntary Heparin Recall by Medtronic

Admin — Sun, 27 Jul 2008 08:28:00 +0000

Medtronic, Inc. today announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action is being taken subsequent to the U.S. Food and Drug Administration’s April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action.

Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. However, the U.S. Food and Drug Administration has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS.

Medtronic has not received reports of any OSCS-related adverse events arising from the use of Carmeda CPB products. It is unclear, however, if exposure to Carmeda-coated medical devices, made with comparatively small amounts of heparin, could cause adverse events similar to those observed with injectable heparin formulations. As a result, Medtronic has initiated a precautionary recall of affected Carmeda products.

In a separate action, Medtronic is advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. Trillium is another biosurface used on CPB products. The amount of heparin on the product is significantly lower than that contained on the Carmeda product. Medtronic’s ultimate goal is to remove contaminated products from the market. However, based on the current data, the benefit of using the affected products outweighs any potential risk to patients. Since the maximum possible patient exposure to heparin from Trillium is extremely low, customers can continue to use the affected Trillium products until a replacement is available.

Heparin Recall and Deaths

Admin — Sun, 27 Jul 2008 08:26:13 +0000

The FDA was in the hot seat on Capitol Hill after a tainted drug was implicated in multiple deaths. A recent study found that more than 80 percent of active ingredients in U.S. drugs come from abroad, but only 11 percent of foreign suppliers are investigated by the FDA.