Safety information for medicinal products containing cefepime as active substance
18.06.2009
The U.S. Food and Drug Administration (FDA) informed about the completion of the assessment procedure for possible increased risk of higher mortality in patients using cefepime. The conclusion was that there were no data indicating increased mortality of patients treated with cefepime in comparison with those treated with other similar medicinal products. Cefepime remains an appropriate therapy for use in approved indications.
Cefepime is a broad spectrum cephalosporin antibiotic used intravenously or intramuscularly in hospital treatment as a reserve antibiotic (used when other antibiotics cannot be used or are not efficacious). Medicinal product with cefepime as active substance approved for marketing in the Republic of Croatia is Maxipime of the marketing authorisation holder PharmaSwiss d.o.o.
The Agency for Medicinal Products and Medical Devices so far has not received any reports on adverse reactions to the active substance cefepime observed in the Republic of Croatia. The Agency will continue to monitor all information concerning safety of the active substance cefepime.
The FDA press release can be found at the following link:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm167427.htm
The Notification by the Agency for Medicinal Products and Medical Devices on the safety of medicinal products containing cefepime as active substance of November 2007, can be found at the following link:
http://www.halmed.hr/Novosti-i-edukacije/Novosti/2007/Podaci-o-sigurnosti-primjene-lijekova-s-djelatnom-tvari-cefepim/149/
