Surgery News - March 2008 - (Page 3) MARCH 2008 • SURGERY NEWS NEWS 3 Heparin Recalled in Wake of Adverse Event Probe B Y E L I Z A B E T H M E C H C AT I E Else vier Global Medical Ne ws axter Healthcare Corp. is voluntarily recalling most of its heparin products because the other major supplier of such products in the United States can make enough to meet demand, the Food and Drug Administration announced Feb. 28. The recall also includes Baxter’s heparin lock flush products, which contain heparin from the same Chinese manufacturer as the multidose and single-dose heparin vials. Heparin from these vials has been associated with a recent spike in severe, allergic-type reactions. The recall does not include Baxter’s parenteral heparin solutions, which contain heparin from another manufacturer. On Feb. 11, the FDA had announced that Baxter had stopped making multipledose vials of heparin because of an increase in reports of severe allergic reactions in patients receiving bolus injections of the company’s heparin. The multidose vials were not recalled then because of concern that there would not be enough heparin available. Baxter supplies about half of the more than 1 million multipledose heparin vials sold in the United States every month. A week later, the FDA said it would send a team to inspect the facility in China in which the active pharmaceutical ingredient from the recalled products is manufactured. Most of the serious reactions have been associated with bolus doses of heparin from the multiple-use vials, with several cases in patients who received a bolus dose of heparin from single-dose vials. But during a briefing on Feb. 28, Dr. Sandra Kweder, deputy director, Office of New Drugs at the FDA’s Center for Drug Evaluation and Research (CDER), said that since Feb. 11, the FDA’s Drug Shortage Team has been working with APP Pharmaceuticals Inc., the other main supplier of heparin multidose and single-dose vials in the United States, to determine if that company could increase production to supply the entire U.S. market. Now that APP can produce sufficient quantities of heparin products, Baxter is recalling its multidose and single-dose vials. As a precaution, Baxter also is recalling its heparin flush product, although there have been no reports of allergic reactions associated with it, Dr. Kweder said. The only Baxter heparin product to remain on the market is its premixed intravenous solutions, which contain 200 U heparin/100 cc in 500-cc and 1,000-cc total volume bags. Dr. Kweder noted that the FDA is continuing its investigation in the United States and China but has not yet identified the underlying cause of the events. After the Feb. 11 announcement, the FDA received more reports of adverse events, including nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, tachycardia, dizziness, unresponsiveness, dyspnea, throat swelling, as well as cases of profound and refractory hypotension, according to Baxter. Nearly all the reports have been in three settings: renal dialysis, invasive cardiovascular procedures, and apheresis procedures. B Including those reported previously, there have been 448 adverse event reports concerning heparin, 389 of which involved Baxter heparin products. The reports have not been fully analyzed, and some may be duplicates, according to Dr. Kweder. A total of 21 deaths has been reported. In nine cases, information about whether the patient received Baxter’s heparin was not included. Four deaths “have the same kind of clinical picture as the allergic-type reactions” that had raised concerns about the Baxter heparin products, she said. The FDA inspection team, which remains in China, has identified “a number of potentially objectionable conditions related to the firm’s manufacturing process” at the facility that makes the active pharmaceutical ingredient from pig intestine, Michael Rogers, director of the Division of Field Investigations in the FDA’s Office of Regulatory Affairs, said during the briefing. These conditions include problems in how the plant evaluates steps used to remove impurities, “issues related to waste material flow,” and deficiencies related to equipment, Mr. Rogers said. It is FDA policy to inspect foreign facilities that provide ingredients for products distributed in the United States. The Chinese facility in question had never been inspected by the FDA, however, because it had been confused with another facility with a similar name that had been inspected by the agency. ■ More information is available at www.fda.gov/cder/drug/infopage/heparin/ default.htm. SIMPLE, SAFE& SOUND Exceptional gram-negative efficacy unprecedented safety The most common adverse reactions were local reactions (up to 2.4%) and systemic reactions such as diarrhea, nausea/vomiting, and rash, which occurred at less than 1.4%. AZACTAM is contraindicated in patients with known hypersensitivity to aztreonam or any other component in the formulation. ® Please see brief summary of prescribing information on adjacent page. © 2005, Elan Pharmaceuticals, Inc. http://www.fda.gov/cder/drug/infopage/heparin/default.htm http://www.fda.gov/cder/drug/infopage/heparin/default.htm
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