Summary ratings: 3 stars
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Published: March 16, 2008
FDA’s wide-ranging investigation into
heparin manufacturing practices, triggered by Baxter Healthcare’s January and February recalls of the blood-thinning drug, has uncovered a
contaminant in the products, one that is present in substantial amounts. "We have found a heparin-like compound that is not heparin present in some active pharmaceutical ingredients (APIs) produced by
Scientific Protein Laboratories (SPL)," announced Janet Woodcock, MD, FDA Deputy Commissioner for Scientific and Medical Programs, Chief Medical Officer, and Acting Director of the Center for drug Evaluation and Research, during a conference call on March 5. She reported that FDA has not made any "direct causal link between the contaminant and the adverse events," but added that the heparin-like contaminant "is present in significant quantities in some of the APIs, accounting for approximately 5% to 20% of the mass of the substance tested." Investigations into the heparin contamination continue, including "inspecting Baxter’s domestic facility, examining heparin product in the U.S. and sending a team of experts to China to conduct a comprehensive inspection of the Changzhou SPL facility that makes the active ingredient for this drug," Woodcock said. FDA will "aggressively investigate" the cause of the contamination, she added. So far, the agency has received 785 reports of adverse events associated with contaminated heparin, including 19 deaths, Woodcock said. During another conference call, held March 6, Woodcock reported a recall of German-manufactured heparin, triggered when the German national drug regulatory authority learned about adverse events similar to those reported in the United States. Unlike the Baxter heparin, the German heparin was not obtained from SPL; it came from other plants in China, according to media reports. To respond to concerns about the safety of all heparin, FDA has released information on two tests—proton nuclear magnetic resonance and capillary electrophoresis—that can detect the presence of the heparin-like contaminant. FDA is requiring these tests be conducted on all heparin products. Regarding a potential shortage of heparin, Woodcock reported that supplies manufactured by APP Pharmaceuticals have been tested and confirmed to be contaminant free. "Fortunately, can provide an adequate supply of heparin vials in the U.S. market," she said. "FDA intends to continue to monitor the availability of heparin and work with manufacturers so that they can continue to meet the demand." Meanwhile, the United States Pharmacopeia (USP) is taking steps toward ensuring the safety of medicines and foods in China and the United States with the signing of a memorandum of understanding (MOU) by Roger L. Williams, MD, USP Executive Vice President and CEO of USP, and Wu Zhen, Secretary-General of the Chinese Pharmacopeia Commission (ChP) and Deputy Commissioner of China’s State Food and Drug Administration. The MOU lists possible collaborations between the two countries, including the following: Updates to existing monograph standards and development of new monographs Third-party certification and verification of manufacturers of ingredients imported into China and of materials exported to the United States Expedited translation of USP compendia into Chinese Quality review of English translation of the Chinese Pharmacopeia A biannual joint scientific symposium conducted by USP and ChP Regular meetings involving senior staff and exchange of scientific staff of USP and ChP “This agreement represents our combined commitment to improving patient care and advancing the public health in the United States and China through rigorous quality standards for medicines,” Williams was quoted as saying in a news release.
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