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FDA issues an Alert and Patient and Healthcare Professional Sheets for Clarithromycin (Biaxin) BETHESDA, MD -- December 12, 2005 -- The United States Food and Drug Administration (FDA) has learned of a placebo controlled study of patients in Denmark with heart disease (the CLARICOR Study), reporting increased mortality in patients treated with clarithromycin (14 days) compared with patients who received a placebo. The observed difference in mortality became apparent after patients had been followed for 1 year or longer after the study drug was given. A mechanism by which 2-weeks of clarithromycin could cause increased mortality measured after 1 year or longer is not clear. Previous trials of antibacterial drugs to prevent heart disease and other trials of clarithromycin have not shown a statistically significant effect on mortality. Considering the results from the CLARICOR study and the results from previous studies of antibacterial drugs to prevent heart disease, the FDA is not recommending any specific changes to the use of clarithromycin at this time. FDA has discussed these findings with the Danish Medicines Agency (DMA) and the FDA recommendation is consistent with that of the DMA. The FDA is providing the summary below to physicians and patients so that they can be aware of the information currently available. The FDA is attempting to get more information regarding the CLARICOR study and its findings. This information reflects FDA's preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about, this information. FDA intends to update this sheet when additional information or analyses become available. Patient Information Sheet [PDF <http://www.fda.gov/cder/drug/InfoSheets/patient/clarithromycinPIS.pdf>] or [HTML <http://www.fda.gov/cder/drug/InfoSheets/patient/clarithromycinPIS.htm>] Healthcare Professional Information Healthcare Professional Sheet [PD <http://www.fda.gov/cder/drug/InfoSheets/HCP/clarithromycinHCP.pdf>F] or [HTML <http://www.fda.gov/cder/drug/InfoSheets/HCP/clarithromycinHCP.htm>] Prescribing Information <http://www.fda.gov/cder/foi/label/2005/050662s038,050698s020,050775s008lbl.pdf> (Biaxin Label) Other Information Clarithromycin is marketed under these names: Biaxin Biaxin XL British Medical Journal Article <http://bmj.bmjjournals.com/cgi/rapidpdf/bmj.38666.653600.55v1> Regulatory History of Clarithromycin from Drugs@FDA <http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchTerm=Clarithromycin&SearchType=BasicSearch> Report Adverse Events to MedWatch <http://www.fda.gov/medwatch/index.html> SOURCE: Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version