Drug Topics - March 10, 2008 - (Page HSE4) 4 HSE DRUG TOPICS MARCH 10, 2008 www.drugtopics.com > > > Clinical Practice Is there room in the market for a recombinant thrombin? Jillene Magill-Lewis, R.Ph. when bovine thrombin shortages occur. Erin Fox, Pharm.D., handles the drug shortage Web site for ASHP. According to Fox, bovine thrombin products have suffered shortages since about 2001, when the number of bovine thrombin manufacturers decreased from several to one. King Pharmaceuticals is now the sole maker of bovine thrombin (Thrombin-JMI). Since 2001, there has been a bovine thrombin shortage in every year except 2007, Fox said. According to J. David Owens, senior VP of hospital sales and marketing for King, there was no shortage in 2007 because the company has revamped its manufacturing facilities to meet increased demand. Aside from shortages, another issue with bovine thrombin is the risk of immune response. In the 1980s, studies revealed that patients developed antibodies to bovine thrombin following exposure to the drug. Although no cross-reactivity with human thrombin was observed, immune responses to other plasma proteins did occur. In 1990, one case was reported in which a patient developed antibodies to bovine thrombin and to bovine factor V. This response turned out to be cross-reactive with human factor V, and life-threatening bleeding was the result. By 2001, some experts were suggesting a recombinant human thrombin was needed. Six years later, that recombinant human thrombin is now a reality. One would expect it to soon corner the thrombin market, but that may not be the case. While there is evidence of the development of antibodies to bovine thrombin, “the clinical relevance of this is unknown,” said Chernin. “In my TIPS TO REMEMBER Recothrom years in the OR, I have never seen a patient have a thrombin allergy listed in [his or Recothrom is for topical use only and should never be inher] medical record.” He added that, to his jected into a patient. knowledge, no intra-operative, allergic reRecothrom can be stored at room temperature (36°to 77°F) actions to thrombin have been observed at for up to two years. SMH. He has read case reports of patients developing Factor V deficiencies that Recothrom is a lyophilized product and must be reconstitutmight have been associated with bovine ed with sterile normal saline. thrombin. However, while some of these patients experienced intra-operative bleedRecothrom, like other topical thrombin products, is indicated ing, others did not. for oozing blood and minor bleeding from capillaries and small A former surgeon concurred: “We’ve venules—it should not be used to treat severe or brisk arterial never seen any correlation between antibleeding. body formation [to bovine thrombin] and here is no doubt that a healthy market for thrombin exists. “This product is used every day in many patients,” said Eric Chernin, R.Ph., a clinical pharmacy specialist at Sarasota Memorial Hospital (SMH) in Sarasota, Fla. Chernin is one of the few pharmacists who practices in the operating room. “Thrombin may be routinely used in a variety of procedures, such as vascular, orthopedic, neurosurgery, and open-heart surgery,” Chernin explained. In fact, bovine thrombin is used in more than one million surgeries annually in the United States, according to ZymoGenetics. ZymoGenetics has developed a recombinant thrombin (Recothrom) and partnered with Bayer to market the product. The Food & Drug Administration gave the two companies the green light to market the product in January. Another human thrombin (Evithrom, Omrix and Johnson & Johnson) is derived from donated plasma and also was recently approved by the FDA. The two new thrombins must now compete with bovine thrombin, which has been on the market for decades. The question is, with the bovine thrombin product well established, will the newer products be able to eke out a market share? The answer is probably a conservative, “Yes.” At the very least, additional thrombin products are needed to fill the void T New Biologic http://www.drugtopics.com
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