In early 2008, the FDA responded to a crisis involving the contamination of heparin, a medication used to prevent and treat blood clots, when the agency received multiple reports of adverse events involving severe allergic reactions. The crisis took place from January 2008 through May 2008, during which time FDA took several actions in its response to the crisis. This report reviewed FDA's management of the heparin crisis. This report examines: (1) how FDA prevented additional contaminated heparin from reaching U.S. consumers; (2) how FDA coordinated its response to the contaminated heparin crisis; and (3) FDA's monitoring and analysis of adverse events associated with heparin. Charts and tables. This is a print on demand report.Officials also told us that at least one of these firms was not shipping crude heparin directly to the United States; however, FDAa#39;s import data show that both firms shipped crude heparin directly to the United States in 2006, which, according toanbsp;...
|Title||:||Food and Drug Administration (FDA)|
|Publisher||:||DIANE Publishing - 2011-05|