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| |  Pfizer Asks Canadian Doctors To Limit Trovan Use To Life-Threatening Infections KIRKLAND, QC -- June 15 -- Pfizer Canada Inc. is asking prescribing physicians to limit the use of its antibiotic Trovan (trovafloxacin/alatrofloxacin) to certain serious life-threatening infections, which are treated in the hospital. Pfizer Canada Inc. will restrict the distribution of Trovan to hospital pharmacies. This voluntary action follows consultation with Health Canada regarding the interpretation of spontaneous reports of rare serious unpredictable hepatic events associated with Trovan through post-marketing surveillance. Post-marketing safety monitoring is performed by Pfizer Inc for all of its products where information on reported adverse events is continuously provided to regulatory authorities worldwide. An estimated 2.5 million prescriptions have been issued for Trovan worldwide since its introduction in February 1998. To date, Pfizer Inc. has reported to regulatory agencies around the world 152 documented cases of serious hepatic adverse events associated with the drug therapy. These include nine spontaneous cases involving hepatic failure where patients required liver transplant and/or died. Trovan was introduced in Canada in January 1999. Pfizer Canada is currently working with Health Canada to update the product labeling in order to reflect the new information. Pfizer Inc. will continue to collect and evaluate data to further understand the incidence of these events. In the interim, Pfizer Canada believes it is prudent and responsible to voluntarily limit the use of Trovan to serious life-threatening infections treated in the hospital, where Trovan has an important role. These infections include hospitalized community-acquired pneumonia, nosocomial pneumonia (hospital-acquired pneumonia), complicated intra-abdominal infections, pelvic infections, complicated skin and skin structure infections. It is recommended that patients currently taking Trovan should NOT discontinue therapy until they have discussed their treatment options with their physician. Pfizer Canada Inc. will be issuing a letter with this new information to prescribing physicians and pharmacists.
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