@entity10964 ( @entity10964 )-associated XXXX . An analysis of German spontaneous reports 1990-2012.

@entity10964 @entity1 @entity3028
PURPOSE: In 1986, the risk of @entity3028 prompted German authorities to restrict the indications for @entity10964 use. After an initial decline, prescriptions increased from <20 million defined daily doses in 1990 to >140 million in 2012. Concurrently, spontaneous reports of @entity3028 increased from about 10 in 1990 to >50 in 2012. In this study, reports were analyzed to identify targets for risk minimization measures. METHODS: Reports of suspected @entity10964 -induced @entity3028 (neutrophils <0.5   *   10(9)  cells/l) between 1990 and 2012 were identified in the German spontaneous reporting database. Cases for which original reporting documents were available were eligible for analysis. @entity1 characteristics, indication, clinical course, and outcome were assessed. RESULTS: One hundred sixty-one reports were analyzed. The mean age of the @entity1 was 56.8  years (11-93) and 64.6  % were female. Off-label use was identified in about 25  % of cases. Neutrophils fell below 100/ l in 63 and intercurrent infections developed in 109 cases. Thirty-eight @entity1 (23.6  %) died. In two thirds of the cases, @entity3028 occurred within 6  weeks of permanent or intermittent @entity10964 treatment, in 30.5  % within 7  days, including 18 cases of immediate onset after the first or second administration. CONCLUSION: The reported cases show severe clinical courses and are, to some extent, a result of off-label use. Due to the absence of individual risk factors and presence of variable onset patterns, risk minimization measures should focus on restricting use to defined clinical situations and providing concise risk information for @entity1 and healthcare professionals.
